MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA PRO 2.5/15; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number 393301

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2019

Event Type  malfunction  

Event Description

It was intended to treat a calcified lesion (70% stenosis degree) in a tortuous lad.The balloon could not be inflated.

Manufacturer Narrative

Based on the analysis, added the product code 1250.The returned instrument 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 pro revealed that the balloon has been inflated.With positive pressure applied, microscopic analysis showed a leakage in the proximal part of the balloon.Small scratches on the balloon surface nearby the damage site were found.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.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause was determined.The final root cause for the leakage is most likely related to patients anatomy.

• Brand Name: PANTERA PRO 2.5/15
• 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: 8438483
• MDR Text Key: 139414775
• Report Number: 1028232-2019-01120
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 07640130437050
• UDI-Public: 7640130437050
• Combination Product (y/n): N
• PMA/PMN Number: K160985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2020
• Device Model Number: 393301
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01172449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1