MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 5/200/130; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	383290
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-35 balloon catheter was selected for treatment of a moderately calcifed total occlusion in the mildly tortuous sfa.During inflation the balloon ruptured at nominal pressure.
Additional Manufacturer Narrative
The complaint instrument was not 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.In addition, a video taken from the angiogram was reviewed.The video shows the complaint instrument being inflated in a calcified sfa.During inflation the balloon opens normally until a pinhole occurs and contrast medium leaks from the distal end of the balloon.Unfortunately, the quality of the video is rather poor.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 tested for air tightness by means of a pressure test and a helium leak test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause is most likely related to the patients anatomy.

• Brand Name: PASSEO-35 5/200/130
• 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: 12648324
• Report Number: 1028232-2021-05764
• Device Sequence Number: 13754445
• Product Code: LIT
• UDI-Device Identifier: 07640130434721
• UDI-Public: 07640130434721
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021

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: 08/31/2022
• Device Model Number: 383290
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08194424
• 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: 10/18/2021
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2019
• 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