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 01/04/2022

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 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.Preliminary photo images of the complaint device were captured by the j&j (b)(4) affiliates.The pre-shipment photos were reviewed by the product analysis lab team.[photo analysis]: based on the photos included in the complaint, the body of the 132cm embovac 71 aspiration catheter is observed to be in a compressed condition.The distal tip is compressed and stretched.The mesh structure was also observed stretched with the mesh exposed.A part of the coating could be noted in torn condition.No other damages could be noted.The original device packing was not shown in the series of photos included in the complaint.The reported issue that the distal end of the complaint device was stretched was confirmed based on the photos; the distal tip is stretched in the photos.The exact time when the stretching occurred cannot be determined.A review of manufacturing documentation associated with this lot (30557978) 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 manufacturing documentation review has no indication that the reported issue is related to the manufacturing process.Further investigation will be performed once the complaint device is returned for evaluation and analysis.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 a thrombectomy procedure with the target lesion between the internal carotid (ic) tip and the m1 segment of the middle cerebral artery; there was much thrombus from the ic top to the m1, the combined technique was used with the 6mm solitaire¿ stent retriever (medtronic) and a 132cm embovac 71 aspiration catheter (ic71132ca / 30557978).All the thrombus was not removed, therefore, a 3mm trevo® retriever (stryker) was used together.Two passes were made and the procedure was completed.The treatment in cerebral infarction (tici) score was a 2b.It was reported that three (3) cm part from the distal end of the embovac device was stretched.The complaint documented that continuous flush was maintained.There was no report of any patient adverse event or complication.Preliminary photo images of the complaint device were captured by the j&j (b)(4) affiliates and included in the complaint on (b)(6) 2022.Based on the review of the photos by the product analysis lab completed on (b)(6) 2022, the distal tip of the complaint device is in a compressed and stretched condition; the mesh structure was also stretched and exposed with the coating observed torn.Based on the review of the photos, the event has been deemed mdr reportable as a ¿malfunction.¿.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 07-feb-2022.[additional information]: on 07-feb-2022, additional information was received.Based on the additional information, the reported event did not result in any consequence or injury to the patient.Excessive force was not applied.Related to the device integrity, the information documented, ¿the altitude changed part which is about 3 cm from the tip was damaged and stretched.It was not split or separated.¿ the complaint product was removed intact (in one piece) from the patient.The reported event did not prolong the procedure.The physician commented that there was severe vessel tortuosity at the internal carotid artery (ic).Updated sections: b.4, g.3, g.6, h.2, 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 that the product analysis lab received the complaint device on 12-feb-2022.The product investigation has been completed on 29-mar-2022.[conclusion]: the healthcare professional reported that during a thrombectomy procedure with the target lesion between the internal carotid (ic) tip and the m1 segment of the middle cerebral artery; there was much thrombus from the ic top to the m1, the combined technique was used with the 6mm solitaire¿ stent retriever (medtronic) and a 132cm embovac 71 aspiration catheter (ic71132ca / 30557978).All the thrombus was not removed, therefore, a 3mm trevo® retriever (stryker) was used together.Two passes were made and the procedure was completed.The treatment in cerebral infarction (tici) score was a 2b.It was reported that three (3) cm part from the distal end of the embovac device was stretched.The complaint documented that continuous flush was maintained.There was no report of any patient adverse event or complication.Preliminary photo images of the complaint device were captured and included in the complaint by the j&j japan affiliates on (b)(6) 2022.The product analysis team reviewed the photos.[photo analysis]: the photos were reviewed on 26-jan-2022.Based on the photos included in the complaint, the body of the 132cm embovac 71 aspiration catheter is observed to be in a compressed condition.The distal tip is compressed and stretched.The mesh structure was also observed stretched with the mesh exposed.A part of the coating could be noted in torn condition.No other damages could be noted.The original device packing was not shown in the series of photos included in the complaint.The reported issue that the distal end of the complaint device was stretched was confirmed based on the photos; the distal tip is stretched in the photos.The exact time when the stretching occurred cannot be determined.A review of manufacturing documentation associated with this lot (30557978) 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 manufacturing documentation review has no indication that the reported issue is related to the manufacturing process.On 07-feb-2022, additional information was received.Based on the additional information, the reported event did not result in any consequence or injury to the patient.Excessive force was not applied.Related to the device integrity, the information documented, ¿the altitude changed part which is about 3 cm from the tip was damaged and stretched.It was not split or separated.¿ the complaint product was removed intact (in one piece) from the patient.The reported event did not prolong the procedure.The physician commented that there was severe vessel tortuosity at the internal carotid artery (ic).The complaint product was returned and received for evaluation and analysis.The investigational finding is documented below.Investigation summary: preliminary photos were provided where the distal tip of the complaint device is in a compressed and stretched condition; the mesh structure was also stretched and exposed with the coating observed torn.A non-sterile 132cm embovac 71 aspiration catheter was received contained in a pouch.Visual inspection was performed.The presence of hydrophilic coating was confirmed.All the conditions observed on the photos provided were observed on the physical product and further evaluation is described below.The mesh section was observed in a stretched condition at 7.5 cm (2.952 inches) from the distal end.Further inspection under microscopic magnification revealed that as a result of the stretching, the mesh structure was exposed, and the coating was observed torn.The catheter shaft was in a compressed condition at 11 cm (4.330 inches) from the distal end, where fingertips seemed to be used to hold or retrieve the device.This reasonably suggests that the damages occurred during the retrieval of the distal part of the catheter.The distal tip was confirmed to be circle-shaped; no damages or anomalies were observed on it.This indicates that there was no difficulty to advance the embovac catheter.The catheter shaft was noted to have a stress mark consistent with bending at 90 cm (35.433 inches) from the distal end, this damage is not considered a contributing factor to the stretching reported and might have occurred during post-operative handling of the catheter.Dimensional inspection: the inner diameter (id) and outer diameter (od) of the embovac catheter was measured and confirmed to be within specifications.Proximal outer diameter (od): 0.0828 inches; specification: max.0.0837 inches, min.0.081 inches.Distal outer diameter (od): 0.0811 inches; specification: max.0.0837 inches, min.0.081 inches.Inner diameter (id): 0.0905 inches; specification: 0.090 inches minimum.The customer complaint regarding the distal end of the embovac being stretched was confirmed based on the evidence observed on the braid mesh section.According to the information captured in the complaint, there were no difficulties before the second pass, since no contributing factors could be identified from the catheter, it is suspected that intraoperative factors contributed to the stretching observed.However, the root cause remains unknown.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 contain the following precaution: exercise care in handling the embovac catheter to reduce the chance of accidental damage.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.

• 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 33025
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 13374383
• MDR Text Key: 284875219
• Report Number: 3008114965-2022-00065
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: IC71132CA
• Device Lot Number: 30557978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2021
• 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: 3MM TREVO® RETRIEVER (STRYKER); 6MM SOLITAIRE¿ STENT RETRIEVER (MEDTRONIC); TREVO TRAK MICROCATHETER (STRYKER)