MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA PRO 2.5/20; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	393308
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The orsiro drug-eluting stent system could not pass the severely calcified lesion in the lad.
Additional Manufacturer Narrative
Corrected the event description.The wrong product was mentioned.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 the reported event.The technical investigation of the returned device showed no irregularities.The balloon is still well folded and its profile complies with the specification.Review of the production documentations confirmed that the instruments were manufactured according to specifications and passed all in-process and final inspections.Based on information provided the remaining lumen diameter in the target lesion was smaller than the crossing profile of the complaint instrument.The reported difficulty in lesion crossing is most likely related to the patients anatomy.
Event or Problem Description
The pantera pro could not pass the severely high calcified lesion in the lad.

• Brand Name: PANTERA PRO 2.5/20
• 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: 8751258
• Report Number: 1028232-2019-02693
• Device Sequence Number: 16571191
• Product Code: LOX
• UDI-Device Identifier: 07640130437128
• UDI-Public: 07640130437128
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K160985
• 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): 07/01/2019

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 Model Number: 393308
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01194112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1