MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2/120/150; PERIPHERAL DILATATION CATHETER

Model Number	366126
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-18 balloon catheter was selected for use.During the procedure, the balloon could not be inflated more than 2 atm.After removal, a hole was detected at the end of the balloon.
Additional Manufacturer Narrative
The returned instrument was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation of the returned product revealed that both the balloon and the device shaft have fractured.The balloon shows clear signs of inflation.The balloon has burst transversally.Microscopic inspection of the balloon fragments showed several deep scratches in close vicinity of the fracture sites.The distal device shaft is severely deformed and has fractured, indicating high tensile force which was most likely applied after the balloon burst.Review of the production documentation of the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test and a pressure test.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.Due to the scratch marks in close vicinity to the fracture sites it seems likely that the balloon burst was induced by the patients anatomy and the fracture of the device shaft is most likely a secondary effect during withdrawal.

• Brand Name: PASSEO-18 2/120/150
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 9632163
• Report Number: 1028232-2020-00401
• Device Sequence Number: 2667621
• Product Code: LIT
• UDI-Device Identifier: 07640130414686
• UDI-Public: 07640130414686
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2020

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: 03/31/2022
• Device Model Number: 366126
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03195963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1