MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 XEO 9/40/90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 428792

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/11/2022

Event Type  malfunction  

Event Description

A passeo-35 xeo balloon catheter was selected for treatment of an aneurysm in the ostial subclavian artery.The device was advanced over the wire and inflated at subclavian artery to post dilate a covered stent.10 bar pressure was applied.The balloon could not inflate further and leaking of contrast was observed in the fluoroscopy.Blood also observed in the syringe of the inflation device.

Manufacturer Narrative

The returned instrument was subjected to a technical analysis and the corresponding 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 of the returned device revealed a transversal cut with a length of 1.5 mm, which penetrates the balloon wall 1 mm distal to the distal x-ray marker.It seems likely that the damage of the balloon surface was caused by a hard, sharp-edged object such as e.G.Anatomical structure.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.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause is most likely related to the patients anatomy.It should be noted that the ifu contraindicates the treatment of lesions that lies within or adjacent to an aneurysm.

• Brand Name: PASSEO-35 XEO 9/40/90
• 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: 13471105
• MDR Text Key: 285159520
• Report Number: 1028232-2022-00626
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 428792
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06212408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• 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