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

Catalog Number IC71132CA

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem Vascular Dissection (3160)

Event Date 02/15/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.The expiration date of the device is not known as the device lot number is not available / not reported.The initial reporter email address is was not reported / available.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported that a (b)(6) male patient underwent mechanical thrombectomy for an acute ischemic stroke and experienced an internal carotid artery (ica) dissection during the procedure.The treating physician was evaluating the 132cm embovac 71 aspiration catheter (ic71132ca / unknown lot number) to treat a patient with acute ischemic stroke.The physician was unable to track the embovac passed the ophthalmic nerve; the device became stuck at the ophthalmic nerve.The embovac was tracked over the physician¿s normal ischemic set up of the prowler select plus (product code and lot number unknown).During an attempt to remove the embovac, a dissection was caused in the ica.As a result, a stent was implanted to treat the ica dissection.It was reported that the procedure was completed successfully, and no device fragments were generated.There was no report of any patient adverse event or complication.The complaint device is not available for evaluation.On 08-mar-2022, additional information was received.The information indicated that the lot number of the embovac device is unknown, but at the time of the event, the lot numbers 30555836 and 30594711 were present at the account.The information indicated that this was an adapt (direct aspiration first pass technique) case; the device was not snaked, it was advanced over a microcatheter and guidewire.Anonymized procedural films / imaging / angiographs of the procedure require permission form the national health trust.The target vessel was not excessively tortuous nor with acute bends.The physician does not suspect and is certain that the prowler select plus microcatheter (606s255fx / lot# unknown) was not involved in the incident.A continuous flush had been maintained through the microcatheter.The cause of the embovac becoming stuck at the ophthalmic nerve is known, but an explanation was not provided.There was no damage noted on the embovac device when it was removed.A neuroform atlas¿ stent (stryker) was used to treat the ica dissection.The event did not result in a clinically significant delay in the procedure.Based on complaint information, the device is not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.The lot number of the device is not known, therefore review of the device history record was not performed.Tracking difficulty, withdrawal difficulty, and vessel dissection are known potential procedural complications associated with the use of the embovac aspiration catheter in mechanical thrombectomy.With the amount of information available and without procedural films, it is not possible to determine the root cause of the event.However, there are vessel characteristics, device selection, operator technique, device interaction, and mechanical manipulation of devices within the artery that may have contributed to the event.There is no indication of a device design or manufacturing issue.Since the alleged withdrawal difficulty from vessel led to ica dissection with the need for surgical intervention, the event is considered serious and mdr reportable.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.

Event Description

The healthcare professional reported that a (b)(6) male patient underwent mechanical thrombectomy for an acute ischemic stroke and experienced an internal carotid artery (ica) dissection during the procedure.The treating physician was evaluating the 132cm embovac 71 aspiration catheter (ic71132ca / unknown lot number) to treat a patient with acute ischemic stroke.The physician was unable to track the embovac passed the ophthalmic nerve; the device became stuck at the ophthalmic nerve.The embovac was tracked over the physician¿s normal ischemic set up of the prowler select plus (product code and lot number unknown).During an attempt to remove the embovac, a dissection was caused in the ica.As a result, a stent was implanted to treat the ica dissection.It was reported that the procedure was completed successfully, and no device fragments were generated.There was no report of any patient adverse event or complication.The complaint device is not available for evaluation.On 08-mar-2022, additional information was received.The information indicated that the lot number of the embovac device is unknown, but at the time of the event, the lot numbers 30555836 and 30594711 were present at the account.The information indicated that this was an adapt (direct aspiration first pass technique) case; the device was not snaked, it was advanced over a microcatheter and guidewire.Anonymized procedural films / imaging / angiographs of the procedure require permission form the national health trust.The target vessel was not excessively tortuous nor with acute bends.The physician does not suspect and is certain that the prowler select plus microcatheter (606s255fx / lot# unknown) was not involved in the incident.A continuous flush had been maintained through the microcatheter.The cause of the embovac becoming stuck at the ophthalmic nerve is known, but an explanation was not provided.There was no damage noted on the embovac device when it was removed.A neuroform atlas¿ stent (stryker) was used to treat the ica dissection.The event did not result in a clinically significant delay in the procedure.

• 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: 13739587
• MDR Text Key: 293149583
• Report Number: 3008114965-2022-00157
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IC71132CA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 0.035 GUIDEWIRE (TERUMO); PROWLER SEL PLUS 150/5CM 45TIP
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male