MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 5/150/130; PERIPHERAL DILATATION CATHETER

Model Number	366134
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The passeo-18 balloon catheter was chosen for treatment of a moderately calcified lesion (85 percent stenosis degree) in the moderately tortuous ostial segment of the left sfa.During pre-dilatation a leakage of the passeo-18 was detected.The balloon was removed, and the balloon was found fractured inside the body.The fractured parts in the vessel were finally removed by surgery, and the patient was stable.
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 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 ruptured 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 was most likely damaged by 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 5/150/130
• 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: 16451914
• Report Number: 1028232-2023-01047
• Device Sequence Number: 5844567
• Product Code: LIT
• UDI-Device Identifier: 07640130414761
• UDI-Public: (01)07640130414761(17)2501
• 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): 05/10/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 366134
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01222721
• 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: 02/23/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown