MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-14 1.5/70/150; PERIPHERAL DILATATION CATHETER

Model Number 380325

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/29/2022

Event Type  malfunction  

Event Description

The passeo-14 balloon catheter was used for pre-dilatation of a moderately calcified lesion with 70 percent stenosis degree, but the balloon could not be inflated and a leakage was found after withdrawal.Another balloon was used to complete the intervention.

Manufacturer Narrative

Neither the complaint instrument nor the angiographic material was returned.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 confirmed that the instrument 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.Based on the conducted investigations, no material or manufacturing related root cause could be determined.

• Brand Name: PASSEO-14 1.5/70/150
• 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: 15433425
• MDR Text Key: 300076093
• Report Number: 1028232-2022-04753
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 07640130433618
• UDI-Public: (01)07640130433618(17)2411
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152240
• 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: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380325
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11212175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• 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