MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2.5/150/130; PERIPHERAL DILATATION CATHETER

Model Number	366130
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-18 balloon catheter was chosen for treatment.It was attempted to pre-dilate a moderately calcified lesion with 90 percent stenosis degree in the right sfa.Two passeo-18 was advanced to the lesion but could not further be inflated when the pressure reached 3 atm (reported separately).The 3rd passeo-18 balloon (complaint device) was used afterwards, but also ruptured.
Additional Manufacturer Narrative
The returned products were subjected to a detailed technical analysis and the corresponding product release documentations was reviewed to establish whether a deviation from the manufacturing processes could be the cause for the reported events.The technical investigation of all three instruments revealed large tears in the balloon surface, all three located at the distal ends of the distal radiopaque markers.Scratches were observed in close vicinity of all tears which have likely been caused by a hard, sharp-edged object such as e.G., anatomical structure.Review of the product release documentations confirmed that the instruments were 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 instruments were delivered in a leak-proof condition.Based on the conducted investigations, no material or manufacturing related root cause could be determined.The root cause for the complaint events is most likely related to the patients anatomy.

• Brand Name: PASSEO-18 2.5/150/130
• 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: 17298488
• Report Number: 1028232-2023-03456
• Device Sequence Number: 3874820
• Product Code: LIT
• UDI-Device Identifier: 07640130414723
• UDI-Public: (01)07640130414723(17)2508
• 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
• Report Date (Section B): 08/16/2023

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: 08/06/2025
• Device Model Number: 366130
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06224359
• 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: 07/03/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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