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

Model Number	366129
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The physician intended to treat a severely calcified lesion (90 percent stenosis degree, vessel reference diameter 6 mm, lesion length 180 mm) in a mildly tortuous bifurcation of the left anterior tibial artery.A passeo-18 balloon catheter was used for the procedure.Initially, it was reported that the balloon of the complaint instrument burst and ruptured in the vessel.After additional correspondence with the local staff it was clarified that the complaint instrument was successfully inflated three times.After balloon deflation, the instrument was withdrawn during which the balloon tore off the catheter.Since the balloon could not be recovered, the patient underwent surgery.The balloon was successfully removed.

• Brand Name: PASSEO-18 2/150/150
• 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: 12370304
• Report Number: 1028232-2021-04800
• Device Sequence Number: 4015035
• Product Code: LIT
• UDI-Device Identifier: 07640130414716
• UDI-Public: 07640130414716
• 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
• Report Date (Section B): 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 366129
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11202139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention