MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-14 1.5/40/150; PERIPHERAL DILATATION CATHETER

Model Number	380319
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-14 balloon catheter was chosen for treatment, but it was not possible to insert the guidewire into the lumen of the balloon catheter.Thus, the passeo 14 pta catheter was flushed for a second time with nacl.However, the nacl came out of the balloon lumen and a leakage was detected.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.During the technical investigation the reported complaint event could be partially reproduced.A 0.014 inch reference guidewire could be introduced into the guidewire lumen with no unusual friction.However, upon flushing the guidewire lumen, water emerged from the inflation port, indicating a potential leakage inside the device hub.Further preparation of the device hub revealed a damage of the inner shaft which has most likely been induced during the welding process.The most probable root cause for the complaint event is related to the manufacturing process.To prevent recurrence the respective internal departments were informed about this case.

• Brand Name: PASSEO-14 1.5/40/150
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 16724987
• Report Number: 1028232-2023-01879
• Device Sequence Number: 12733439
• Product Code: LIT
• UDI-Device Identifier: 07640130433557
• UDI-Public: (01)07640130433557(17)2406
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 380319
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05212520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown