MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2.5/200/130; PERIPHERAL DILATATION CATHETER

Model Number	376297
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 balloon catheter was chosen for treatment.Initially it was reported that the guide wire was stuck in the guide wire lumen of the passeo-18 system and could not be withdrawn.After return of the product it was detected that the guide wire has fractured and a part remained in the guide wire lumen of the device.
Additional Manufacturer Narrative
The technical analysis of the returned instrument was performed and the manufacturing history of the product was reviewed to determine whether there was any deviation that could account for this event.The technical investigation revealed that the balloon is not well folded anymore and shows signs of inflation.About 1.1 cm distal to the proximal xray marker the fractured distal guidewire fragment is stuck in the guidewire lumen and could not be pushed out.The fragment is plastically deformed and residue of dried contrast medium.The outer diameter of the inner shaft complies with the specification.The usable length of the device was also found to be in specification.A 0.018 inch reference guidewire could be introduced with no unusual friction until reaching the fragment in the balloon area.The review of the manufacturing history did not reveal any nonconformity.The device in question successfully passed all inprocess controls as well as the final inspection.We can therefore confirm that the device was in accordance with the specifications at the time of delivery.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.It seems likely that the root cause for the complaint event is related to external factors during the procedure.The guidewire most likely fractured due to application of high tensile force.

• Brand Name: PASSEO-18 2.5/200/130
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 8915775
• Report Number: 1028232-2019-03609
• Device Sequence Number: 10894039
• Product Code: LIT
• UDI-Device Identifier: 07640130430044
• UDI-Public: 07640130430044
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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: 05/31/2022
• Device Model Number: 376297
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05196092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1