MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-14 3/220/150; PERIPHERAL DILATATION CATHETER

Model Number 380352

Device Problems Deflation Problem (1149); Fracture (1260)

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

Event Date 08/12/2021

Event Type  malfunction  

Event Description

The passeo-14 balloon catheter was selected for treatment of a severely calcified lesion (100 percent stenosis degree) in the mildly tortuous anterior tibial artery.The balloon was slow to deflate after first and second use.When balloon was being removed from sheath on negative pressure, it got stuck about 5cm out and the balloon broke away from the catheter/proximal connecter.It was stated by the physician that it still had contrast in it and he believed that the balloon was still intact.He released the pressure and put on negative again.After waiting for bubbles to stop, he used force to remove balloon.This caused proximal end of the balloon to break away from shaft.No device part remained in patient.

Manufacturer Narrative

The returned product was subjected to a technical analysis and the product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed a severe deformation of the outer shaft distal portion.The outer shaft is elongated and constricted.A large amount of contrast medium residue is still present in the inflation lumen.The balloon has detached from the outer shaft at the proximal balloon weld.The device dimensions do not comply anymore with the specification.The findings indicate application of a high tensile force.Due to the state of the instrument the in- and deflation behavior could not be assessed.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, 100 percent controls of the device dimensions are performed and the tensile force at the balloon weld is tested in a defined amount of samples from every lot.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause for the reported event is most likely related to the handling during the procedure (i.E.Insufficient deflation time).The balloon fractured as a result of tensile overload.It should be noted that the ifu instructs the user to deflate balloons exceeding 2.5 mm diameter and 100 mm length for at least 45 seconds, and to maintain vacuum whenever the dilatation catheter is subsequently advanced or withdrawn.

• Brand Name: PASSEO-14 3/220/150
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 12394694
• MDR Text Key: 269043042
• Report Number: 1028232-2021-04882
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 07640130433885
• UDI-Public: 07640130433885
• Combination Product (y/n): N
• PMA/PMN Number: K152240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 380352
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09200367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1