MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 XEO 7/40/130; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 428864

Device Problem Inflation Problem (1310)

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

Event Date 09/30/2022

Event Type  malfunction  

Event Description

A passeo-35 xeo balloon catheter was selected for treatment of a moderately calcified lesion (80 percent stenosis degree) in the moderately tortuous external iliac artery.The balloon catheter could not be inflated.Another passeo-35 xeo worked without problems.

Manufacturer Narrative

The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The balloon of the affected instrument is well folded and shows no signs of inflation.Microscopic inspection revealed a severe deformation of the device shaft below the kink protector just distal to the device hub.This deformation causes an obstruction of the guidewire lumen.The guidewire used in the intervention was not returned for analysis.A 0.035 inch reference guidewire could not be introduced through the deformed device shaft.Review of the production documentation confirmed that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations, no material or manufacturing related root cause was identified.The final root cause for the reported event could not be determined.

• Brand Name: PASSEO-35 XEO 7/40/130
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 15715141
• MDR Text Key: 302943869
• Report Number: 1028232-2022-05626
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K142379
• 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: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 428864
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08212835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• 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