MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 3/80/90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	383235
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-35 balloon catheter was selected for treatment of a severely calcified lesion (95 percent stenosis degree) in an av fistula.The device was used for pre-dilatation, but the balloon could not be inflated anymore when it reached 6 atm.Another balloon was used to finish the procedure.
Additional Manufacturer Narrative
The returned product was subjected to a 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.The technical investigation of the returned device revealed that the balloon has not been inflated but was returned in a partially unfolded state.The complaint product shaft is kinked at several locations.No contrast medium residue was observed in the balloon- and inflation lumen.Functional testing was performed by inflating the product with 7 atm (np) and 20 atm (rbp).The balloon inflated normally, did not show any damage or leakage, and could be deflated normally.The inflated diameter was measured with 3.0 mm and is in specification.Review of the production documentation confirmed that the product was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each product is inflated and tested for air tightness by means of a pressure test and a helium leakage test.Based on the conducted investigations of the device being subject to this complaint, we can confirm that no product failure could be determined.

• Brand Name: PASSEO-35 3/80/90
• 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: 18219428
• Report Number: 1028232-2023-06030
• Device Sequence Number: 17560792
• Product Code: LIT
• UDI-Device Identifier: 07640130434172
• UDI-Public: (01)07640130434172(17)2504
• 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): 01/08/2024

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: 04/30/2025
• Device Model Number: 383235
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03223136
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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