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

Catalog Number IC71132CA

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.Based on the photos provided, the embovac could be noted with a compressed section on the distal body.No other damages could be noted.Only a part of the device was shown.A manufacturing record evaluation was performed for the finished device 30392893 number, and no non-conformances related to the reported complaint condition were identified.The reported condition ¿catheter (body/shaft)- unraveled/stretched¿ was confirmed since the device could be noted compressed on the distal section and this condition may be related to the issue reported by the user.The reported condition ¿catheter (body/shaft)- withdrawal difficulty-through sheath¿ could not be evaluated based on the pictures.However, the compressed condition noted on the device may have been contributed to the reported failure.The mre suggests that the failure reported by the customer could not be related to the manufacturing process.No corrective action will be taken at this time.Further investigation will be performed if the device returns for analysis.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by the field, during a thrombectomy case, a 132cm embovac 71 aspiration catheter (ic71132ca, 30392893) was not able to be removed through the sheath after aspiration in left m1 (arch type 3).The user had to pull very strong and the embovac refused to be removed.They could feel that the catheter was stretching.Further pull, had the desired outcome of removing the embovac.The embovac became trapped inside the bended tip of a neuron max.The device was removed by having the neuron max partially removed, until the kinking was not a problem.The cause of the event or factors contributing to the event are unknown.No excessive force was applied to the device.Adequate flush was maintained through the devices.There were no issues with the unknown microcatheter (mc).The device was inspected for damage prior to use and there was no damage.The procedure was prolonged by 10 minutes due to the event.Device pictures were provided.

Manufacturer Narrative

Product complaint (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a thrombectomy case, a 132cm embovac 71 aspiration catheter (ic71132ca, 30392893) was not able to be removed after aspiration in left m1 (arch type 3).The user had to pull very strong and the embovac refused to be removed.They could feel that the catheter was stretching.Further pull, had the desired outcome of removing the embovac.The embovac became trapped inside the bent tip of a neuron max.The device was removed by having the neuron max partially removed until the kinking was not a problem.The cause of the event or factors contributing to the event is unknown.No excessive force was applied to the device.Adequate flush was maintained through the devices.There were no issues with the unknown microcatheter (mc).The device was inspected for damage prior to use and there was no damage.The procedure was prolonged by 10 minutes due to the event.Additional information received indicated that this was an adpt (direct aspiration first pass technique) case.The device was not snaked (advanced without wire/microcatheter).There was regular vessel tortuosity.The procedure was completed by removing together both the neuron max and the embovac.There was no patient injury reported.Based on the photo provided for this complaint, the embovac could be noted with a compressed section on the distal body.No other damages could be noted.Only a part of the device was shown.A manufacturing record evaluation was performed for the finished device 30392893 number, and no non-conformances related to the reported complaint condition were identified.One non-sterile 132cm embovac 71 asp.Catheter was received inside of a pouch.The received device was visually inspected, and it was found kinked at 8 cm, 47 cm and 85 cm, a stretch condition was observed on the device, also exposed wires were noted during the analysis.The id and od from the device was measured and was found within specification.The complaint reported by the customer ¿catheter (body/shaft) - unraveled/stretched¿ was confirmed, during the analysis, the catheter was found with a stretch condition with exposed wires.This condition is related with the customer¿s complaint and could be related as noted in the event description, the user having to ¿pull very strong¿ when trying to remove the embovac.The stretched condition noted on the device is apparently related to the handling of the device at the time of the procedure.The complaint reported by the customer ¿catheter (body/shaft) - withdrawal difficulty-through sheath¿ could not be duplicated because the complaint reported by the customer is specific to the patient and the procedure at the time of occurrence and cannot be replicated in the lab.However, based on the event description and the finding during the analysis, the customer complaint was confirmed.The stretch condition is a result of the withdrawal difficulty at the procedure time and an excessive force applied to the device at the removal time.Neither the analysis nor the mre suggests that the failure reported by the customer could be related to the manufacturing process.The instructions for use (ifu) warns the user to not advance or withdraw the intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the device against resistance may cause vessel injury or damage to the device.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.Stretching can also be caused by the application of excessive force to a device, as noted in the event description.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

Manufacturer Narrative

Product complaint#: (b)(4).Section b5: additional information received indicated that this was an adpt (direct aspiration first pass technique) case.The device was not snaked (advanced without wire/microcatheter).There was regular vessel tortuosity.The procedure was completed by removing together both neuron max and embovac.There was no patient injury reported.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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
• MDR Report Key: 10851972
• MDR Text Key: 234345653
• Report Number: 3008114965-2020-00525
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• PMA/PMN Number: K193380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2020

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: 03/31/2021
• Device Catalogue Number: IC71132CA
• Device Lot Number: 30392893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 11/19/2020; 12/09/2020
• Supplement Dates FDA Received: 12/08/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NEURON MAX.