MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 132CM EMBOVAC 71 ASP. CATHETER; EMBOVAC ASPIRATION CATHETER

Catalog Number IC71132CA

Device Problem Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Initial reporter name, phone and email address of the initial reporter are not available / reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.[photo analysis]: preliminary photo images of the complaint device were captured by the j&j japan affiliates and included in the complaint file.Based on the photos, the embovac catheter has a crushing appearance (i.E., compressed and flattened) along the entire length of the device.The distal portion (braided mesh) can be observed with a stretched appearance.The coating appeared torn as a consequence of the stretched condition noted on the distal portion of the catheter.A review of manufacturing documentation associated with this lot (30578755) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The reported issue documented in the complaint is confirmed based on the photos provided.Further investigation and device assessment will be performed when the device is returned.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that a patient with a history of intracranial atherosclerotic disease (icad) underwent a thrombectomy procedure targeting an occlusion in the distal m1 segment.When the 132cm embovac 71 aspiration catheter (ic71132ca / 30582692) was attempted to be inserted into the 8f optimo guiding catheter (tokai medical) by using the attached insertor as per the instructions for use (ifu).However, the distal part of the embovac device was not able to be insertor.It was replaced with another 132cm embovac 71 aspiration catheter (ic71132ca / 30578755), and the first pass was performed.When the catheter was removed from the patient after the first pass, it was checked and the part 10cm from the tip was damaged as if it was stretched.Details of the procedure is reported as follows: the 8f optimo guiding catheter was raised to the neck and guide the embovac to the proximal m1.For the thrombus in the distal m1, a 5mm x 37mm embotrap iii revascularization device (et309537 / 21l143av) was deployed and retracted inside the embovac (ic71132ca / 30578755) via the aspiration catheter with a proximal balloon (asap) technique.The thrombus could not be removed due to the patient¿s icad condition.When the physician took the suction catheter out of the patient, the part 10cm from the tip was damaged as if it was stretched.The degree of the damage suggested that blood flow might flow through the gap in the braids in the catheter braided mesh structure.Suction pump (medela) was used.It was reported that mechanical thrombectomy was stopped after the first pass with the embotrap iii and the medication was administered to the patient.Continuous flush was maintained.Preliminary photos of the complaint device(s) were captured by the j&j japan affiliates and included in the complaint file on 15-may-2022.Based on the review of the photos by the product analysis lab completed on 20- may-2022, the distal portion of the complaint device appeared stretched, the coating has a torn appearance as a consequence of the stretched condition.Based on the review of the photos, the event has been deemed mdr reportable as a ¿malfunction.¿ on 24-may 2022, the cerenovus sales representative provided the following additional information: the embotrap iii (et309537 / 21l143av) was used to remove a thrombus at the distal m1 segment in the patient with intracranial atherosclerotic disease (icad).Mechanical thrombectomy was stopped after the first pass.The thrombus could not be removed due to the icad.There is no indication of device malfunction associated with the embotrap iii device.Medication and ¿other unknown treatment¿ were provided to the patient because the mechanical thrombectomy was not successful.The suction pump (medela company) was used with the embovac (lot 30578755).The suction pump was to aspirate the thrombus via embovac catheter during the co-aspiration technique with the embotrap iii device.Details of the medication is unknown, but the sales rep.Confirmed that the medication was for the treatment of the thrombus occlusion in the distal m1 segment which could not be retrieved due to the icad.The sales rep heard from the physician that the mechanical thrombectomy was stopped due to the icad condition, and not due to the performance of the embovac or to the embotrap iii device.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 02-jun-2022.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.10.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that a patient with a history of intracranial atherosclerotic disease (icad) underwent a thrombectomy procedure targeting an occlusion in the distal m1 segment.When the 132cm embovac 71 aspiration catheter (ic71132ca / 30582692) was attempted to be inserted into the 8f optimo guiding catheter (tokai medical) by using the attached insertor as per the instructions for use (ifu).However, the distal part of the embovac device was not able to be insertor.It was replaced with another 132cm embovac 71 aspiration catheter (ic71132ca / 30578755), and the first pass was performed.When the catheter was removed from the patient after the first pass, it was checked and the part 10cm from the tip was damaged as if it was stretched.Details of the procedure is reported as follows: the 8f optimo guiding catheter was raised to the neck and guide the embovac to the proximal m1.For the thrombus in the distal m1, a 5mm x 37mm embotrap iii revascularization device (et309537 / 21l143av) was deployed and retracted inside the embovac (ic71132ca / 30578755) via the aspiration catheter with a proximal balloon (asap) technique.The thrombus could not be removed due to the patient¿s icad condition.When the physician took the suction catheter out of the patient, the part 10cm from the tip was damaged as if it was stretched.The degree of the damage suggested that blood flow might flow through the gap in the braids in the catheter braided mesh structure.Suction pump (medela) was used.It was reported that mechanical thrombectomy was stopped after the first pass with the embotrap iii and the medication was administered to the patient.Continuous flush was maintained.Preliminary photos of the complaint device(s) were captured by the j&j japan affiliates and included in the complaint file on (b)(6) 2022.Based on the review of the photos by the product analysis lab completed on (b)(6) 2022.[photo analysis]: preliminary photo images of the complaint device were captured by the j&j japan affiliates and included in the complaint file.Based on the photos, the embovac catheter has a crushing appearance (i.E., compressed and flattened) along the entire length of the device.The distal portion (braided mesh) can be observed with a stretched appearance.The coating appeared torn as a consequence of the stretched condition noted on the distal portion of the catheter.A review of manufacturing documentation associated with this lot (30578755) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The reported issue documented in the complaint is confirmed based on the photos provided.On 24-may 2022, the cerenovus sales representative provided the following additional information: the embotrap iii (et309537 / 21l143av) was used to remove a thrombus at the distal m1 segment in the patient with intracranial atherosclerotic disease (icad).Mechanical thrombectomy was stopped after the first pass.The thrombus could not be removed due to the icad.There is no indication of device malfunction associated with the embotrap iii device.Medication and ¿other unknown treatment¿ were provided to the patient because the mechanical thrombectomy was not successful.The suction pump (medela company) was used with the embovac (lot 30578755).The suction pump was to aspirate the thrombus via embovac catheter during the co-aspiration technique with the embotrap iii device.Details of the medication is unknown, but the sales rep.Confirmed that the medication was for the treatment of the thrombus occlusion in the distal m1 segment which could not be retrieved due to the icad.The sales rep heard from the physician that the mechanical thrombectomy was stopped due to the icad condition, and not due to the performance of the embovac or to the embotrap iii device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: the complaint device was received.Visual inspection was performed.The presence of the hydrophilic coating was confirmed.The device was observed to be slightly kinked at 131 cm, 130 cm, and 129 cm from the distal end, also the tip of the device was noted to be compressed.During the visual inspection, no other damages or anomalies were observed.The braided mesh was visually inspected, and it was found to be stretched and compressed.Under magnification, the coating has a torn appearance as a consequence of the stretched condition at 10 cm from the distal end.The hydrophilic coating separation is secondary to the stretching which in turn could have been caused by the retraction of the embotrap inside the embovac and the proximal balloon used during the procedure since according to the information provided, the thrombus could not be removed due to the patient¿s intracranial atherosclerotic disease (icad) condition, this could have generated a collapse on the braided mesh reflected in the stretched, compressed, and hydrophilic coating separation conditions.Based on the findings noted on the braided mesh the customer complaint was confirmed.However, there is no indication that the issue reported in the complaint is a result of a defect inherently related to the complaint device.The device was confirmed to be within specifications for the hub inner diameter (id) and outer diameter (od), however, the distal inner diameter could not be evaluated due to the compressed condition observed on the tip of the device.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: ¿ exercise care in handling the large bore catheter to reduce the chance of accidental damage.¿ torquing the large bore catheter excessively while kinked may damage the device, resulting in separation of the catheter shaft.Withdraw the entire device (the device, microcatheter, and guidewire) if the device is severely kinked.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 22-jun-2022.[additional information]: on 22-jun-2022, additional information was received.The information indicated that when the physician took the 132cm embovac 71 aspiration catheter (ic71132ca / 30578755) out of the patient¿s body, the part 10cm from the tip was damaged and appeared as if it was stretched.Per the information, the degree of the damage suggested that blood might flow through the gap between the braids in the braided mesh structure.Slight crushing was observed in the distal area.The catheter could not be moved due to the resistance.Excessive force was not applied to the device.E.1: initial reporter phone: 0438-36-1071.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: 132CM EMBOVAC 71 ASP. CATHETER
• Type of Device: EMBOVAC ASPIRATION CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN AND SHURTLEFF INC.(MIRAMAR); 3260 executive way; miramar FL
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14492926
• MDR Text Key: 300454263
• Report Number: 3008114965-2022-00364
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: IC71132CA
• Device Lot Number: 30578755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 132CM EMBOVAC 71 ASP. CATHETER; 8F OPTIMO GUIDING CATHETER (TOKAI MEDICAL); EMBOTRAP III 5 MM X 37 MM; SUCTION PUMP (MEDELA); TREVO TRAK 21 MICROCATHETER (STRYKER)