MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 2.5/15; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367015
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo coronary balloon catheter was selected for treatment.When removing the balloon protector, the transportation wire/stylet was found kinked and punctured the physicians glove, which cause bleeding on physicians finger.
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 complaint device was returned separately with the transportation wire and the protector.The technical investigation of the returned product revealed that the complaint instrument is undamaged beside of a slight kink in the hypotube.The protector is a little damaged at its distal end.On the transportation wire, no scaling or foreign material could be found, the reported kink of the transportation wire could not be confirmed.The returned transportation wire could be inserted and removed without any resistance and a reference transportation wire could be inserted and removed without any resistance as well.The distal end of the transportation wire is no longer in specification as it has been bent open during the attempt of removal.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.The issues in removing the transportation wire could not be reproduced.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.

• Brand Name: PANTERA LEO 2.5/15
• 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: 10737627
• Report Number: 1028232-2020-04640
• Device Sequence Number: 17014952
• Product Code: LOX
• UDI-Device Identifier: 07640130415737
• UDI-Public: 07640130415737
• 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): 10/26/2020

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: 05/31/2023
• Device Model Number: 367015
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05201926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1