MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 6/40/130; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	357311
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-35 peripheral balloon catheter was selected for treatment of a severely calcified lesion (stenosis degree: 90 percent) in the mildly tortuous mid left upper limb vein.During expansion and when the pressure reached 12 kpa, the passeo-35 balloon ruptured but did not reach the maximum pressure for that catheter (14 kpa).The patient reported significant pain in the left forearm, and the balloon was replaced to continue the procedure.
Additional Manufacturer Narrative
03-jun-2024 new information: an av-fistular was treated.Neither the complaint product nor the angiographic material was returned for analysis.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each device is inflated followed by a pressure test before balloon folding and a helium leakage test to confirm the air tightness.All devices of the relevant lot passed these tests.We can therefore confirm that the device was delivered in a leak-proof and pressure-tight condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference capa# nc-24-004.Neither the complaint product nor the angiographic material was returned for analysis.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each device is inflated followed by a pressure test before balloon folding and a helium leakage test to confirm the air tightness.All devices of the relevant lot passed these tests.We can therefore confirm that the device was delivered in a leak-proof and pressure-tight condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• Brand Name: PASSEO-35 6/40/130
• 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: 19393845
• Report Number: 1028232-2024-02872
• Device Sequence Number: 7772380
• Product Code: DQY
• UDI-Device Identifier: 07640119558400
• UDI-Public: (01)07640119558400(17)2606
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2024

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: 06/04/2026
• Device Model Number: 357311
• Device Catalogue Number: 357311
• Device Lot Number: 05232843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 06/03/2024; 11/12/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/03/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• 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