MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 5/200/90; PERIPHERAL DILATATION CATHETER

Model Number	376281
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A passeo-18 balloon catheter was chosen for an antegrade treatment of the afs together with a command.018 wire.During dilatation of the balloon up to np pressure, the balloon ruptured and was withdrawn but kept hooking at the end of the 4f sheath.When the balloon catheter was out of the patient, it was seen that the balloon was not complete, some parts did remain in the afs.Removal of these parts out of the vessel was not successful, it was decided to stop the procedure.A bypass surgery is planned soon.
Additional Manufacturer Narrative
The returned instrument was subjected to a 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 instrument was returned fractured in at least two parts.The hub has been cut off and was not returned for investigation.The distal fragment (distal end of the balloon, the tip, the inner shaft, and the distal x-ray marker) was not returned.At the proximal fragment the device inner shaft is plastically deformed, indicating application of a high tensile force.The balloon shows clear signs of inflation.The balloon has burst diagonally.In close vicinity of the tear scratches were observed which have likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure.The introducer sheath was not returned.Review of the lot release verification confirmed that the complaint instrument was manufactured according to specifications and successfully passed all in-process inspections as well as the final inspection.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The balloon has most probably burst due to the patients anatomy, and the instrument then fractured as a result of tensile overload during withdrawal into the introducer sheath.It should be noted that the ifu instructs the user to pull out the dilatation catheter and the introducer sheath together in case of withdrawal difficulties.

• Brand Name: PASSEO-18 5/200/90
• 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: 16134396
• Report Number: 1028232-2023-00106
• Device Sequence Number: 3212882
• Product Code: LIT
• UDI-Device Identifier: 07640130429888
• UDI-Public: (01)07640130429888(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): 01/09/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2025
• Device Model Number: 376281
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07225611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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