MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 3.75/15; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number 367020

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2019

Event Type  malfunction  

Event Description

A pantera leo balloon catheter was chosen for treatment of a severely calcified lesion in the proximal rca.During inflation the balloon ruptured at 16 atm and was therefore removed from the patient's body.The procedure was finished with another balloon.

Manufacturer Narrative

The returned device was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation of the returned pantera leo revealed a longitudinal tear in the distal half of the balloon.Further microscopic analysis showed several deep scratches on the balloon surface at several locations.The review of the production documentation of the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.The balloon burst in longitudinal direction was most likely induced by the severely calcified lesion.

• Brand Name: PANTERA LEO 3.75/15
• Type of Device: BASIC CORONARY ANGIOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 9460119
• MDR Text Key: 170517976
• Report Number: 1028232-2019-05557
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 07640130415782
• UDI-Public: 07640130415782
• Combination Product (y/n): N
• PMA/PMN Number: K163660
• 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: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 367020
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01191777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1