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

Catalog Number IC71132CA

Device Problems Material Puncture/Hole (1504); Difficult to Remove (1528); Stretched (1601)

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

Event Date 06/29/2022

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.The initial reporter phone: (b)(6) 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.Investigation findings / investigation conclusions: the ¿no findings available¿ code was used in the investigational findings because the actual complaint device has not been received.This code corresponds to the code ¿cause not established¿ code in the investigation conclusions.The four (4) medical imaging included in the complaint underwent independent physician review on (b)(6) 2022.The results of the physician review is documented as follows: the description of the case is clear and so is the problem described.Four images are provided which show an occlusion of the a3 segment with a microcatheter in that location.The embovac is in the first 1/3 of the a2 on the right side.Given the diameter of the a2 (1.0-2.8 mm in publications) and the size of the a1 (on average 2.0 mm) in combination with the angle of the vessels, it is conceivable that there is vasospasm occurring in either of the segments involved due to a size mismatch.The size of the embovac (0.081¿ corresponding to 2.05 mm) may have been too large to be positioned in the a2 with the anatomy as depicted in the images.From the description it is not clear whether spasmolytics were administered to facilitate release of the catheter.Regarding the damage to the catheter, an analysis by the r&d team is necessary to report on the extent and mechanism.Physician name and date reviewed: (b)(6) , neurointerventionalist.(b)(6) 2022.The three (3) photos of the complaint device were reviewed by the product analysis lab team and is documented below.The distal portion of the 132cm embovac 71 aspiration catheter was shown.The braided mesh can be noted severely stretched.The coating has a torn appearance due to the noted stretched condition on the distal portion of the catheter.The reported issue in the complaint was confirmed.This is based solely on the photos provided.If when the complaint device is returned, an assessment will be performed as per the conditions of the returned device.A review of manufacturing documentation associated with this lot (30582686) 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.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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 during thrombectomy procedure, there was an unpleasant experience with an 132cm embovac 71 aspiration catheter (ic71132ca / 30582686) used in combination with a prowler select microcatheter (catalog/lo# unknown) and an embotrap iii revascularization device (catalog/lot# unknown).The procedure is as follows: from the segment of the anterior cerebral artery, the physician was able to retrieve the embotrap iii device, but the embovac could not be pulled out of the vessel.The last resort was to pull on the catheter, which was associated with a stretching of the material.When the destroyed catheter was rinsed, a hole appeared in the material.The physician commented that ¿fortunately, there was no vascular rupture.¿ there was no report of any patient adverse event or complication.The complaint documented that there was no procedure delay due to the reported issue and the procedure was successfully completed.On (b)(6) 2022 , additional information was received.The information indicated that there was excessive vessel tortuosity in the target vessel.The procedure was not an adapt (direct aspiration first pass technique).An adequate flush had been maintained.Prior to the reported issue with retrieving the embovac from the vessel, the device had not been advanced nor withdrawn against resistance.Related to whether additional intervention was needed to remove the device from the patient, the additional information indicated that, ¿the embovac could no longer be pushed back or forward.Only with a lot of force could the embovac be pulled back and recovered.Afterwards, the embovac was collapsed in the distal area and strongly bruised.¿.

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 during thrombectomy procedure, there was an unpleasant experience with an 132cm embovac 71 aspiration catheter (ic71132ca / 30582686) used in combination with a prowler select microcatheter (catalog/lo# unknown) and an embotrap iii revascularization device (catalog/lot# unknown).The procedure is as follows: from the a2 segment of the anterior cerebral artery, the physician was able to retrieve the embotrap iii device, but the embovac could not be pulled out of the vessel.The last resort was to pull on the catheter, which was associated with a stretching of the material.When the destroyed catheter was rinsed, a hole appeared in the material.The physician commented that ¿fortunately, there was no vascular rupture.¿ there was no report of any patient adverse event or complication.The complaint documented that there was no procedure delay due to the reported issue and the procedure was successfully completed.On 18-jul-2022, additional information was received.The information indicated that there was excessive vessel tortuosity in the target vessel.The procedure was not an adapt (direct aspiration first pass technique).An adequate flush had been maintained.Prior to the reported issue with retrieving the embovac from the vessel, the device had not been advanced nor withdrawn against resistance.Related to whether additional intervention was needed to remove the device from the patient, the additional information indicated that, ¿the embovac could no longer be pushed back or forward.Only with a lot of force could the embovac be pulled back and recovered.Afterwards, the embovac was collapsed in the distal area and strongly bruised.¿ the complaint included three (3) photos of the complaint device and four (4) procedure imaging.The device photos and the procedure images were reviewed.The four (4) medical imaging included in the complaint underwent independent physician review on 12-jul-2022.The results of the physician review is documented as follows: the description of the case is clear and so is the problem described.Four images are provided which show an occlusion of the a3 segment with a microcatheter in that location.The embovac is in the first 1/3 of the a2 on the right side.Given the diameter of the a2 (1.0-2.8 mm in publications) and the size of the a1 (on average 2.0 mm) in combination with the angle of the vessels, it is conceivable that there is vasospasm occurring in either of the segments involved due to a size mismatch.The size of the embovac (0.081¿ corresponding to 2.05 mm) may have been too large to be positioned in the a2 with the anatomy as depicted in the images.From the description it is not clear whether spasmolytics were administered to facilitate release of the catheter.Regarding the damage to the catheter, an analysis by the (b)(6) team is necessary to report on the extent and mechanism.Physician name and date reviewed: (b)(6), md, neurointerventionalist.12-jul-2022.The three (3) photos of the complaint device were reviewed by the product analysis lab team and is documented below.The distal portion of the 132cm embovac 71 aspiration catheter was shown.The braided mesh can be noted severely stretched.The coating has a torn appearance due to the noted stretched condition on the distal portion of the catheter.The reported issue in the complaint was confirmed.This is based solely on the photos provided.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 132cm embovac 71 aspiration catheter was received contained in the decontamination pouch.Visual inspection was performed.The presence of the hydrophilic coating was confirmed.As seen in the photos provided, the braided mesh was observed to be in a stretched condition through all the distal section.Further inspection was performed under the microscope.Under magnification, it was observed that as a result of the stretching, the coating was observed to have a torn / frayed appearance.The catheter was then flushed to check for leakage.Water was observed leaking from a hole that was caused by the severity of the stretched condition observed and noted.The inner diameter (id) and outer diameter (od) of the 132cm embovac 71 aspiration catheter was confirmed to be within specifications.The withdrawal difficulty documented in the complaint is most specific to the patient at the procedure time, but the stretched appearance and subsequent rupture (observed as leakage) of the returned catheter seems to be a translation of the difficulty of withdrawing the device.Withdrawal difficulty is a known procedural occurrence associated with the use of this device.With the limited information available and the evidence obtained from the device inspection, there is no clear insight into the root cause and/or exact contributing factors that may have resulted in the observed withdrawal difficulty.Factors not described in the information provided, such as patient¿s anatomy, device manipulation, operator¿s technique, may have contributed to the issue encountered rather than the manufacture of the device.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.A review of manufacturing documentation associated with this lot (30582686) 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.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) contains the following precaution: exercise care in handling the embovac catheter to reduce the chance of accidental damage.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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 report that the product was received in the product analysis lab on 04-aug-2022.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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; 33025 FL 33025
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15048308
• MDR Text Key: 304707979
• Report Number: 3008114965-2022-00470
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 30582686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 08/04/2022; 09/06/2022
• Supplement Dates FDA Received: 08/04/2022; 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• 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