MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 3.5/20; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367030
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo balloon catheter was chosen for treatment.During procedure the balloon could not be inflated.
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 pantera leo was returned with the transportation wire being stuck in the guidewire lumen.The guidewire lumen is severely deformed and has fractured distal to the guidewire exit port, indicating high tensile force.Inspection of the stuck transportation wire revealed that its protector is upside down, which implies that the transportation wire had once been removed from the instrument and was most likely put back.Due to the severe deformation of the guidewire lumen, a guidewire could not be completely introduced.The reported inflation issues therefore could not be reconstructed.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• Brand Name: PANTERA LEO 3.5/20
• 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: 8774216
• Report Number: 1028232-2019-02815
• Device Sequence Number: 2038996
• Product Code: LOX
• UDI-Device Identifier: 07640130415881
• UDI-Public: 07640130415881
• 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): 07/04/2019

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 Model Number: 367030
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04190898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1