MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 2.5/8; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	366993
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera-leo balloon catheter was chosen for treatment of a severely calcified lesion in a distal rca.The device could not cross the lesion.
Additional Manufacturer Narrative
The returned instrument 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 the reported event.The technical investigation of the returned instrument showed that the balloon has not been inflated but its profile does not comply with the specification anymore.According to the provided information the remaining lumen diameter in the target lesion was smaller than the crossing profile of the complaint instrument.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 of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The final root cause is most likely related to the patients anatomy.

• Brand Name: PANTERA LEO 2.5/8
• 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: 8884506
• Report Number: 1028232-2019-03324
• Device Sequence Number: 2715991
• Product Code: LOX
• UDI-Device Identifier: 07640130415515
• UDI-Public: 07640130415515
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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: 12/31/2021
• Device Model Number: 366993
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01190235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1