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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo coronary balloon catheter was selected for treatment of a severely calcified lesion (93 percent stenosis degree) in the severely tortuous mid lad.Pressure was applied (20 atm) but the balloon did not inflate properly.Contrast medium leaked from balloon.
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 instrument revealed a small tear in the balloon about 3.5 mm distal to the proximal x-ray marker.Scratches were observed in the balloon surface in close vicinity to the tear.The damage of the balloon surface was most likely caused by a hard, sharp-edged object pressing against the balloon from the outside.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, no manufacturing or material related root cause could be determined.The root cause is most likely related to the patients anatomy (i.E.Severe calcification).

• 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: 11544570
• Report Number: 1028232-2021-01362
• Device Sequence Number: 3147781
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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: 08/31/2023
• Device Model Number: 367004
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08203082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1