MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 2.75/12; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367005
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo balloon system was chosen for treatment of a moderately calcified lesion (90 percent stenosis degree) in the lad.After two inflations up to 16 atm, the balloon ruptured at 14 atm during third inflation.
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.During functional testing the balloon was successfully inflated with 14 atm (np), but the pressure could not be held and water was found leaking from the guidewire exit port.Microscopic inspection of the guidewire exit port revealed that both the guidewire lumen and the inflation lumen are 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 2.75/12
• 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: 10077265
• Report Number: 1028232-2020-02108
• Device Sequence Number: 2862088
• Product Code: LOX
• UDI-Device Identifier: 07640130415638
• UDI-Public: 07640130415638
• 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): 05/19/2020

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: 11/30/2020
• Device Model Number: 367005
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11176007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1