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

Model Number	393301
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was intended to treat a calcified lesion (70% stenosis degree) in a tortuous lad.The balloon could not be inflated.
Additional 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
• Common Device Name: 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
• Report Number: 1028232-2019-01120
• Device Sequence Number: 2249907
• Product Code: LOX
• UDI-Device Identifier: 07640130437050
• UDI-Public: 7640130437050
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1