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	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo balloon catheter was chosen for treading a severely calcified lesion in the lad by retrograde approach through a bypass graft.When the instrument was withdrawn after inflation it was noticed that the shaft broke at its distal end.The fractured part remained inside the patient.
Additional Manufacturer Narrative
Added information per follow-up report: due to the confidential policy of the hospital the correct patient status was not reported immediatly.Patient had cardiac arrest on iva occlusion; resuscitation.Despite the reopening of the iva, the patient died.Neither the complaint instrument nor the angiographic material or a cathlab report was provided for analysis.Therefore no technical investigation on the subject could be performed.The manufacturing history was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.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 of the device being subject to this complaint, no material or manufacturing related root cause was determined.The final root cause is most likely related to external factors during the procedure.

• 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: 8992380
• Report Number: 1028232-2019-03928
• Device Sequence Number: 276336
• Product Code: LOX
• UDI-Device Identifier: 07640130415737
• UDI-Public: 07640130415737
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/09/2019

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 Expiration Date: 09/30/2021
• Device Model Number: 367015
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10183205
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1