MAUDE Adverse Event Report: BIOTRONIK AG PANTERA LEO 3.0/8; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number 366995

Device Problems Burst Container or Vessel (1074); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2018

Event Type  malfunction  

Event Description

During post-dilatation it was difficult to apply any pressure.Thus the device was removed from the patients body and a pinhole was detected.

Manufacturer Narrative

(b)(6) 2018 - corrected device problem code.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 technical investigation revealed that the balloon has been in- and deflated.Microscopic inspection revealed a pinhole about 2 mm proximal to the distal x-ray marker and scratches were found nearby the damage site.The 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.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material root cause was determined.

• Brand Name: PANTERA LEO 3.0/8
• 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: 7348792
• MDR Text Key: 102743805
• Report Number: 1028232-2018-00908
• 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
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 366995
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10170079
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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