MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 2.5/12; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367004
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The pantera leo balloon catheter was chosen for treatment of a severely calcified lesion (90 percent stenosis degree) in the lad.After preparation of the lesion with a cutting balloon the device was inserted but it was not possible to inflate the balloon.Thus, the device was removed from patients body.
Additional Manufacturer Narrative
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 product revealed that the balloon has been inflated and was deflated in the as-returned condition.The balloon does not show any damage or irregularity.A strong kink was observed in the device shaft about 5 mm distal to the guidewire exit port.During functional testing the balloon could be inflated, but the pressure could not be held and water was found leaking from the guidewire exit port.Microscopic inspection revealed a damage of the inflation lumen being located at the kink.In addition, the guidewire exit port was found sliced open.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The damage at the guidewire exit port is most likely related to the handling of the device during the intervention.

• Brand Name: PANTERA LEO 2.5/12
• 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: 10589645
• Report Number: 1028232-2020-04083
• Device Sequence Number: 2627974
• Product Code: LOX
• UDI-Device Identifier: 07640130415621
• UDI-Public: 07640130415621
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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: 01/31/2021
• Device Model Number: 367004
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01185152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1