MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PROWLER SELECT PLUS 150/5CM; CATHETER, CONTINUOUS FLUSH

Model Number 606-S255X

Device Problems Material Too Soft/Flexible (4007); Physical Resistance/Sticking (4012)

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

Event Date 03/29/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during a stent-assisted endovascular embolization procedure, a micro guidewire, and a 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown) were introduced into the parent artery.The physician opened the packaging of the complaint stent, a 4.5mm x 37mm enterprise® vascular reconstruction device (enc453712 / 7107408) to inspect its integrity and took the stent from the dispenser hoop.The physician pinched the protective sheath and the delivery guidewire to prevent the stent from releasing during the removal process.The physician introduced the stent into the y-connector, advanced the stent and delivered it to the target position.When the physician was attempting to release the stent, the position of the microcatheter and the stent shifted.The physician retracted the stent intending to adjust the position of the microcatheter, but during the stent withdrawal, it became obstructed at the proximal end of the microcatheter and the delivery wire broke.A new microcatheter and a new stent were used to complete the procedure.It was reported that the lot number of the prowler select plus microcatheter is unobtainable and the device is not available to be returned.There was no report of any negative patient impact.On (b)(6) 2023, additional information was received.The information indicated procedure was targeting an aneurysm on the c7 segment of the internal carotid artery (ica).Adequate continuous flush was maintained through the microcatheter.The stent component was no longer on the delivery wire when it was removed from the patient.The information indicated that the delivery wire did break into two (2) pieces.The information confirmed that there was no patient injury or complication due to the reported product issues.The replacement stent was another 4.5mm x 37mmenterprise® vascular reconstruction device (enc453712) and the replacement microcatheter was another 150cm x 5cm prowler select plus microcatheter (606s255x).The reported event did not result in any clinically significant delay in the procedure.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.D.4: the expiration date of the device is not known as the device lot number is not available / not reported.E.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.H.4: the device manufacture date is not known as the device lot number is not available / not reported.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 complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00216 and 3008114965-2023-00217.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to make a correction to the conclusion statement associated with the manufacturing documentation review related to the 150cm x 5cm prowler select plus microcatheter (606s255x).The 3500a initial medwatch report incorrectly documented that a manufacturing documentation review was performed for the concomitant 150cm x 5cm prowler select plus microcatheter (606s255x).The lot number was not available; therefore, manufacturing documentation review was not performed.The corrected conclusion is as follows: with the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed the lot number of the device is not known; therefore, manufacturing documentation review not performed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00216 and 3008114965-2023-00217.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.The 3500a initial medwatch report incorrectly documented that a manufacturing documentation review was performed for the concomitant 150cm x 5cm prowler select plus microcatheter (606s255x).The lot number was not available; therefore, manufacturing documentation review was not performed.

• Brand Name: PROWLER SELECT PLUS 150/5CM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16747608
• MDR Text Key: 313723992
• Report Number: 3008114965-2023-00217
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028888
• UDI-Public: 10886704028888
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K021591
• 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
• Report Date: 05/03/2023

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 Model Number: 606-S255X
• Device Catalogue Number: 606S255X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/03/2023
• 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: EU 4.5X37MM STENT 12 MM DW TIP.