MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 2.75/15; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367016
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo balloon system was used for pre-dilatation 3-4 times and no issue was noted.The same device was used again but pressure could not be hold up to 26 atm.After removal no damage on balloon was detected.The device was reinserted again but inflation was not possible.Another balloon catheter was used for post dilatation.
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 this event.The complaint instrument has been inflated and was returned in a deflated state.As part of the technical investigation, functional testing was performed.The complaint device could be inflated to np, bp and even up to the reported complaint pressure of 26 atm (6 atm over rbp), and pressure could be held.At these pressures no apparent damage or leakage was observed.Thus, the reported event could not be confirmed.Review of the production documentation of the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.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, we can confirm that no product failure could be determined.

• Brand Name: PANTERA LEO 2.75/15
• 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: 9960572
• Report Number: 1028232-2020-01687
• Device Sequence Number: 16846084
• Product Code: LOX
• UDI-Device Identifier: 07640130415744
• UDI-Public: 07640130415744
• 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): 04/09/2020

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: 05/31/2022
• Device Model Number: 367016
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06190474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1