MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 7/60/80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	357296
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-35 balloon catheter was selected for treatment of a moderately calcified lesion with 80 percent stenosis degree in the moderately tortuous sfa.The balloon easily reached the lesion without resistance and without using force.When the balloon inflation was attempted, there was no reading on the atm dial and the balloon was not inflating on fluoro.It was noticed that the inflation fluid was in fact leaking out of the wire lumen.
Additional Manufacturer Narrative
The returned instrument 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.In addition, a video taken in the cathlab was reviewed.In the video provided the physician attempts to inflate the balloon with a syringe via the inflation port of the complaint instrument during which water leaks out of the guidewire port.The technical investigation showed that the balloon has been inflated and was partially deflated in the as-returned state.Functional testing was performed during which the balloon opened but the pressure did not hold since water was leaking from the guidewire port.The reported complaint event could thus be reproduced.However, despite detailed microscopic inspection and subsequent dissection of the instrument, the leakage site could not be identified.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is inflated and tested for air tightness by means of a pressure test and a helium leakage test.Based on the conducted investigations, no material or manufacturing related root cause was identified.The final root cause for the reported event could not be determined.

• Brand Name: PASSEO-35 7/60/80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 17735781
• Report Number: 1028232-2023-04539
• Device Sequence Number: 5492726
• Product Code: DQY
• UDI-Device Identifier: 07640119558257
• UDI-Public: (01)07640119558257(17)2603
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082933
• 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): 11/06/2023

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: 03/21/2026
• Device Model Number: 357296
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03231074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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