MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PROWLER SELECT PLUS 170/15 CM; CATHETER, CONTINUOUS FLUSH

Model Number 606-S272X

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The lot number was not reported.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 company is seeking this information through the event investigation.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 mechanical thrombectomy of the left cerebral media artery, the inner liner of a 170/15 cm prowler select plus (606s272x, unknown lot) was ¿rubbed off¿ after two maneuvers with stent retrievers (first, embotrap 2 5x33mm and second, solitaire x 4x40mm).The microcatheter was replaced, not by a prowler select plus.The surgery was delayed by three minutes due to the reported event.The procedure was successfully completed.There was no patient consequences reported.There was no performance issues with the embotrap.A continuous flush was maintained through the microcatheter.There was resistance between the microcatheter and the stent retrievers after the inner liner was gone.The friction between the stent retriever and the microcatheter increased.That was the cause of the microcatheter being replaced.There was no report of any coating flakes ending up in the patient.Additional intervention was not needed to remove the device from the patient.

Manufacturer Narrative

Product complaint #: (b)(4).Section b5: additional intervention was not needed to remove the device from the patient.Additional information received indicated that there was no unusual resistance or friction felt before the inner liner of the catheter ¿rubbed off¿.The same embotrap was used with the replaced microcatheter after the reported issue.No excessive force was applied at any time.Complaint conclusion: as reported by the field, during a mechanical thrombectomy of the left cerebral media artery, the inner liner of a 170/15 cm prowler select plus (606s272x, unknown lot) was ¿rubbed off¿ after two maneuvers with stent retrievers (first, embotrap 2 5x33mm and second, solitaire x 4x40mm).The microcatheter was replaced, not by a prowler select plus.The surgery was delayed by three minutes due to the reported event.The procedure was successfully completed.There was no patient consequences reported.There was no performance issues with the embotrap.A continuous flush was maintained through the microcatheter.There was resistance between the microcatheter and the stent retrievers after the inner liner was gone.The friction between the stent retriever and the microcatheter increased.That was the cause of the microcatheter being replaced.There was no report of any coating flakes ending up in the patient.Additional intervention was not needed to remove the device from the patient.Additional information received indicated that there was no unusual resistance or friction felt before the inner liner of the catheter ¿rubbed off¿.The same embotrap was used with the replaced microcatheter after the reported issue.No excessive force was applied at any time.The device was discarded; therefore, no further investigation can be performed at this time.The lot number is not known; therefore, a device history record review cannot be completed.With the information available and without the product available for analysis, the reported customer complaint of ¿coating ¿ delaminated¿ could not be confirmed.Per the instructions for use (ifu), the device should be introduced through microcatheters indicated for the delivery of therapeutic devices in the neurovasculature of a size ¿18¿ or larger, with a minimum internal diameter of 0.021¿ and an overall length of not more than 155 cm, e.G.Trevo 18, merci 18l, headway 21, cantata, velocity 025,marksman 27, and excelsior xt-27 microcatheters.Performance of the device with other microcatheters that have not been evaluated may be different.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices; however, it is possible that clinical and procedural factors, including device manipulation / interaction and device selection may have contributed to the reported issue.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: PROWLER SELECT PLUS 170/15 CM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 10503583
• MDR Text Key: 208821234
• Report Number: 3008114965-2020-00402
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028895
• UDI-Public: 10886704028895
• Combination Product (y/n): N
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

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 Model Number: 606-S272X
• Device Catalogue Number: 606S272X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EMBOTRAP II 5X33 REVASC. DEV.; SOLITAIRE X 4X40MM.