MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-18 6/80/130 CATHETER, ANGIOPLASTY, BALLOON DILATATION

Model Number 366124

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Claudication (2550)

Event Date 05/21/2018

Event Type  malfunction  

Event Description

Ous mdr: it was reported that the passeo-18 balloon was used for a pta on (b)(6) 2018. On (b)(6) 2018 the patient returned to the hospital due to a short distance claudication and during examination of the vessel a foreign material was detected in the distal sfa/popliteal artery. Should additional information be provided this file will be updated.

Manufacturer Narrative

The investigation of the returned balloon protector was able to confirm it as the protector which is initially mounted to protect the balloon. Further two kinks were observed at its distal end, most probably as consequence of the removal. The provided angiographic images from the initial procedure have been reviewed and did not lead to any further information regarding the nature of the complaint. Review of the manufacturing history of the product detailed above did not reveal any non-conformity. The device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection. Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined. The event is related to known external factors, because the protector was not removed prior to insertion of the balloon. Please note that the instruction for use (ifu) states to: carefully remove the balloon protector by pulling on the very distal end of the protector.

• Brand Name: PASSEO-18 6/80/130
• Type of Device: CATHETER, ANGIOPLASTY, BALLOON DILATATION
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; buelach CH-81 80; SZ CH-8180
• MDR Report Key: 7846113
• MDR Text Key: 119255415
• Report Number: 1028232-2018-03029
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K072765
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/30/2020
• Device Model Number: 366124
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11175268
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 09/05/2018 Patient Sequence Number: 1