MAUDE Adverse Event Report: BIOTRONIK AG PANTERA LEO 3.0/12; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number 367006

Device Problems Fracture (1260); Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2017

Event Type  malfunction  

Event Description

Ous mdr - after post dilatation the pantera leo balloon snapped inside the patient.The system was removed and all parts were retrieved safely.The patient is a (b)(6) male.

Manufacturer Narrative

It was reported that the complaint instrument fractured during withdrawal.All parts of the device could be removed from the patient.Review of the manufacturing history of the production lot did not reveal any nonconformity.The complaint instrument was manufactured according to specifications and successfully passed all in-process inspections as well as the final inspection.The technical investigation revealed that the device has fractured at the guide wire exit port.The tearing edges of both fragments are plastically deformed, indicating that the fractures occurred due to tensile stress exceeding the tensile strength of the outer shaft.The balloon of the complaint instrument has been in and deflated; microscopic inspection of the balloon was inconspicuous.Based on the conducted investigation of the device being subject to this complaint, no manufacturing related root cause could be determined.The device was most likely mechanically overloaded before it fractured.However, due to the state of the device and the lack of information regarding the procedure itself it remains unclear if for instance the balloon was not fully deflated upon withdrawal or if the guiding catheter could have caused the problem.

• Brand Name: PANTERA LEO 3.0/12
• Type of Device: BASIC CORONARY ANGIOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; buelach CH-81 80; SZ CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 6383674
• MDR Text Key: 69275038
• Report Number: 1028232-2017-00718
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K163660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 367006
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08165571
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1