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

Model Number	606-S255FX
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2020
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.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, the tip of a prowler sel plus 150/5cm 45tip (606s255fx, 30061145) cracked.There was no patient injury reported.No additional information was provided at the time of the report.
Additional Manufacturer Narrative
Product complaint # pc-(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, the tip of a prowler sel plus 150/5cm 45tip (606s255fx, 30061145) cracked.There was no patient injury reported.No additional information was provided at the time of the report.One non-sterile unit prowler sel plus 150/5cm 45tip was received inside of a pouch.The received device was visually inspected, body of the device was found in good conditions.The distal tip of the device was found compressed at 0.4cm from the distal end, no other damages were observed.The id and od from the prowler was measured and was found within specification.A manufacturing record evaluation was performed for the finished device 30061145 number, and no non-conformances related to the reported complaint condition were identified the complaint reported by the customer ¿brite tip/distal tip - cracked¿ was not confirm.The cracked condition was not found on the received device.The compress condition noted on the device appears to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the analysis nor the mre suggest that the failure reported could be related to the manufacturing process.The instructions for use (ifu) indicate to inspect the catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a catheter that has been damaged in any way.If damage is detected, replace with another envoy guiding catheter that is not damaged.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.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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.
Additional Manufacturer Narrative
Product complaint # : (b)(4).The purpose of this mdr is to include the additional event information received on 4/28/2020.The additional event information resulted in a change in the reportability of this complaint.Therefore, it has been deemed not reportable.No further reports will be forthcoming.Updated sections on this report: b5, g4, g7, h2 and h10.Section b5: additional information received indicated that there was a kinked and not a crack on the tip.Product analysis updated based on the additional information received: : one non-sterile unit prowler sel plus 150/5cm 45tip was received inside of a pouch.The received device was visually inspected, the body of the device was found in good condition.The distal tip of the device was found compressed at 0.4cm from the distal end, no other damages were observed.The id and od from the prowler were measured and were found within specification.The complaint reported by the customer ¿brite tip/distal tip - kinked/bent¿ the device was found compressed and this may be related to the reported complaint and due to this we can confirm the complaint.The compress condition noted on the device appears to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the analysis nor the mre suggests that the failure reported could be related to the manufacturing process.

• 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 neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 9847559
• Report Number: 1226348-2020-00022
• Device Sequence Number: 19554914
• Product Code: KRA
• UDI-Device Identifier: 10886704028857
• UDI-Public: 10886704028857
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2020

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: 04/25/2018
• Device Model Number: 606-S255FX
• Device Catalogue Number: 606S255FX
• Device Lot Number: 30061145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 03/25/2020; 04/28/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/14/2020; 05/04/2020
• 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: OG CMPLX XTRASOFT COIL 2.5X3.5.; OG TDL CMPLX FILL COIL 5X10.