MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PROWLER SEL PLUS 150/5CM 45TIP; CATHETER, CONTINUOUS FLUSH

Model Number	606-S255FX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.(b)(6).The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.This information was not provided in the reported event or available at the time of report submission.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 1226348-2020-00033.Based on the photos provided of the prowler select plus microcatheter, it can be determined that the prowler sel plus 150/5cm 45tip has a compressed condition on the distal tip at 1cm from the distal end.The rest of the device could be observed with no damages.The reported condition ¿catheter (body/shaft) - obstructed with mc loss of cerebral target position¿ could not be evaluated based on the pictures.Further investigation will be performed once the device returns for analysis.A manufacturing record evaluation was performed for the finished device 30296214 number, and no non-conformances related to the reported complaint condition were identified.
Event or Problem Description
As reported by a healthcare professional, a 4mmx23mm enterprise2 no tip stent delivery system (enc402300,10998144), was inserted into a concomitant microcatheter, 150/5cm 45tip prowler sel plus (606s255fx, 30296214) but there was intensive resistance felt at 5cm from the distal tip.It was not able to be advanced anymore.It was removed from the patient and replaced with another device and the procedure was completed.The customer states there is no additional information available.Pre-shipment pictures of the prowler select plus microcatheter were received.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this report: d10, g4, g7, h2, h3, h6 and h10.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 a healthcare professional, a 4mmx23mm enterprise2 no tip stent delivery system (enc402300,10998144), was inserted into a concomitant microcatheter, a 150/5cm 45tip prowler sel plus (606s255fx, 30296214) but there was intensive resistance felt at 5 cm from the distal tip.It was not able to be advanced anymore.It was removed from the patient and replaced with another device and the procedure was completed.The customer states there is no additional information available.One non-sterile prowler sel plus 150/5cm 45tip mpd unit was received inside of a pouch.The received device was visually inspected, and the distal tip of the device was found compressed.No other damages were observed.The received mc was flushed using a lab sample syringe.After that, a guide wire.018¿¿ lab sample was introduced into the received mc and it advances, then the wire got stuck at a point coinciding with the compress found in the device.The guide couldn't go any further.The id and od from the prowler was measured and was found within specification.A manufacturing record evaluation was performed for the finished device 30296214 number, and no non-conformances related to the reported complaint condition were identified the complaint reported by the customer ¿catheter (body/shaft) - obstructed with mc loss of cerebral target position¿ was confirmed, on the functional test the guidewire got stuck and couldn¿t go any further.The stuck condition match with the compress condition found on the device.The compress condition observed on the catheter may have appeared to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Procedural factors and handling process may contribute to the failure as reported.The instructions for use (ifu) caution that if unusual friction is still noticed during advancement or retraction of the coil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire catheter system and examine for damage.Replace it with a new system.If friction still exists, withdraw and examine the delivery catheter system.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.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.

• Brand Name: PROWLER SEL PLUS 150/5CM 45TIP
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CHE-2 400; SZ CHE-2400
• MDR Report Key: 9978349
• Report Number: 1226348-2020-00034
• Device Sequence Number: 3329794
• Product Code: KRA
• UDI-Device Identifier: 10886704028857
• UDI-Public: 10886704028857
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 606-S255FX
• Device Catalogue Number: 606S255FX
• Device Lot Number: 30296214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENTERPRISE2 4MMX23MM NO TIP.