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	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo coronary balloon catheter was selected for treatment of a moderately calcified lesion (75 percent stenosis degree) in the rca.The balloon ruptured during inflation at 18 atm.Another balloon catheter was used for the intervention.It was stated that it occurred due to calcification.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was returned for analysis.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.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.The instrument was delivered in a leak-proof condition.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause could be determined.Considering the physicians statement, the balloon burst was most likely induced by the patients anatomy (i.E.Severely calcified lesion).

• 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: 11595549
• Report Number: 1028232-2021-01542
• Device Sequence Number: 3474031
• 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): 03/31/2021

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: 06/30/2023
• Device Model Number: 366997
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06201966
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1