MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2.5/200/130; PERIPHERAL DILATATION CATHETER

Model Number	376297
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 balloon catheter was selected for treatment of the tibial-peroneal trunk.During inflation, when the pressure reached 2 bar, the balloon ruptured.The patient was stable, no further actions were performed.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed that the balloon has burst longitudinally over a length of about 72 mm, starting about 2 mm proximal to the proximal radiopaque marker.Microscopic inspection of the balloon surface revealed scratches in close vicinity of the tear which have likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure.Review of the product release 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 tested for air tightness by means of a helium leak test and a pressure test.We can therefore confirm that the device was delivered in a leakproof condition.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The root cause for the complaint event is most likely related to the patients anatomy.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was returned.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 tested for air tightness by means of a pressure test and a helium leak test.Based on the conducted investigations, no manufacturing related root cause could be determined.

• Brand Name: PASSEO-18 2.5/200/130
• Common Device Name: PERIPHERAL DILATATION CATHETER
• 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: 17871087
• Report Number: 1028232-2023-05029
• Device Sequence Number: 15353747
• Product Code: LIT
• UDI-Device Identifier: 07640130430044
• UDI-Public: (01)07640130430044(17)2509
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072765
• 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,Followup
• Report Date (Section B): 11/16/2023

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: 09/13/2025
• Device Model Number: 376297
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08224054
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 10/18/2023; 11/16/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 10/25/2023; 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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