MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 4.0/8; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	366999
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The pantera leo balloon catheter was selected to treat a severely calcified lesion in the medial lad.During the procedure it was not possible to inflate the balloon at all.
Additional Manufacturer Narrative
The returned device was subjected to a 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 revealed that the guidewire lumen and the distal out shaft are severely deformed, indicating high tensile force.A reference transportation would not pass the deformation zone, indicating that the deformation has occurred after the transportation wire was removed.The complaint device could be inflated and deflated without any problems.The reported inflation problem could not be confirmed.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The deformation of the guidewire lumen is most likely related to external factors during the procedure.

• Brand Name: PANTERA LEO 4.0/8
• 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: 8897185
• Report Number: 1028232-2019-03474
• Device Sequence Number: 13525499
• Product Code: LOX
• UDI-Device Identifier: 07640130415577
• UDI-Public: 07640130415577
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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: 09/30/2021
• Device Model Number: 366999
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09186784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR