MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 5/120/130; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 383278

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2023

Event Type  malfunction  

Manufacturer Narrative

Neither the complaint instrument nor the angiographic material was returned for analysis.Therefore, no technical investigation on the subject could be performed.The product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.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 before balloon folding followed by a pressure test and a helium leakage test to confirm the air tightness.All instruments of the relevant lot passed these tests.The instrument 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.

Event Description

A passeo-35 balloon catheter was selected for treatment.During attempt to dilate an arteriovenous fistula, the balloon could not be inflated, and the device was withdrawn.Another balloon was used to finish the procedure.

• Brand Name: PASSEO-35 5/120/130
• Type of Device: 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: 17755378
• MDR Text Key: 323500174
• Report Number: 1028232-2023-04561
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 07640130434608
• UDI-Public: (01)07640130434608(17)2508
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K082933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383278
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07223449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1