MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 3.5/12; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367008
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo coronary balloon catheter was selected for treatment of a severely calcified lesion (90 percent stenosis degree) in the moderately tortuous lad.The pantera leo was inflated up to np twice.During the second inflation the balloon ruptured.The pantera leo was removed together with the guidewire.
Additional Manufacturer Narrative
The returned product 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 this event.The technical investigation revealed that the balloon has been inflated and was deflated in the as-returned state.During analysis a 0.014 inch reference guidewire could not be fully introduced.A 0.015 inch reference transportation wire could also not be fully introduced.The inner shaft was found deformed (i.E.Flattened) about 70 mm proximal to device tip.The guidewire used in the intervention was not returned.The complaint instrument could be inflated to np and rbp without leakage or pressure loss and deflated within specification.The reported balloon burst could not be confirmed.Review of the production documentation for the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Every instrument is shipped with a 0.015 inch transportation wire that covers the full guidewire lumen.No difficulties in removing the transportation wire have been reported.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.The instrument was thus in accordance with the specifications at the time of delivery.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.

• Brand Name: PANTERA LEO 3.5/12
• 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: 11568870
• Report Number: 1028232-2021-01422
• Device Sequence Number: 3621469
• Product Code: LOX
• UDI-Device Identifier: 07640130415669
• UDI-Public: 07640130415669
• 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): 03/25/2021

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: 01/31/2023
• Device Model Number: 367008
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02202000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1