MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2/40/90; PERIPHERAL DILATATION CATHETER

Model Number	366099
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 balloon catheter was chosen for treatment of a severely calcified lesion (100 percent stenosis degree) in the mildly tortuous distal popliteal artery.It was not possible to inflate the passeo-18 balloon catheter due to a balloon rupture.Originally reported on mdr-1028232-2022-02569, but the device information was incorrect.Submitting this report with the correct information and closing original report.
Additional Manufacturer Narrative
The returned device 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 this event.The technical investigation revealed that the returned instrument is severely deformed at the tip.The balloon is slightly unfolded, and blood was found inside of the inflation lumen and in the balloon lumen.Pressure could not be built up as a leakage was observed in the shaft.On the proximal balloon weld, the shaft shows a deep tear, reaching through the wall of the shaft, causing the leakage.A long longitudinal scratch was observed following the tear in proximal direction.Review of the product release documentation verified that the instrument detailed above was manufactured according to specifications.The device fulfilled all the requirements of in-process and final inspection.Further, the delivery system is visually checked to 100% for damages.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test and a pressure test.The instrument was delivered in a leak-proof condition.Based on the conducted investigations no material or manufacturing related root cause could be identified.

• Brand Name: PASSEO-18 2/40/90
• 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: 14455121
• Report Number: 1028232-2022-02614
• Device Sequence Number: 20437727
• Product Code: LIT
• UDI-Device Identifier: 07640130414419
• UDI-Public: 07640130414419
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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: 03/31/2024
• Device Model Number: 366099
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03213927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female