MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 3/150/130; PERIPHERAL DILATATION CATHETER

Model Number 366131

Device Problem Inflation Problem (1310)

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

Event Date 12/18/2023

Event Type  malfunction  

Event Description

A passeo-18 peripheral balloon catheter was selected for pre-dilatation of a lesion with 75 percent stenosis degree in the right sfa, but the balloon could not be inflated after reaching the lesion.The pressure was very low and did not record.Another device was used to finish the procedure.

Manufacturer Narrative

Neither the affected device nor the angiographic material was returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a pressure test and a helium leak test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no material or manufacturing related root cause could be determined.

• Brand Name: PASSEO-18 3/150/130
• 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: 18502333
• MDR Text Key: 332768380
• Report Number: 1028232-2024-00208
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 07640130414730
• UDI-Public: (01)07640130414730(17)2502
• 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,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 366131
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02223296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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