MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 3.5/8; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	366997
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo balloon was chosen to treat a severe calcified lesion (83 percent stenosis degree) in a severe tortuous lad.Despite repeated attempts it was not possible to 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 slightly unfolded.According to the provided information the remaining lumen diameter in the target lesion was smaller than the crossing profile of the balloon.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 3.5/8
• 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: 8889861
• Report Number: 1028232-2019-03427
• Device Sequence Number: 311715
• Product Code: LOX
• UDI-Device Identifier: 07640130415553
• UDI-Public: 07640130415553
• 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): 08/09/2019

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: 02/28/2022
• Device Model Number: 366997
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03194911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 08/13/2019
• 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