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

Model Number 366134

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2022

Event Type  malfunction  

Manufacturer Narrative

Neither the complaint instrument nor the angiographic material was returned for analysis.Therefore, no technical investigation on the subject could be performed.The product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the product release documentation for the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.

Event Description

A passeo-18 balloon catheter was chosen for treatment of a 200mm long lesion with 95 percent stenosis degree in the lower limb artery.Despite pre-dilatation, the lesion could not be crossed with the device.

• Brand Name: PASSEO-18 5/150/130
• Type of Device: 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: 15129213
• MDR Text Key: 296866644
• Report Number: 1028232-2022-03846
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 07640130414761
• UDI-Public: 07640130414761
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 366134
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11213833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Date Device Manufactured: 11/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1