MAUDE Adverse Event Report: BIOTRONIK AG PANTERA LEO 2.5/20; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number 367026

Device Problem Burst Container or Vessel (1074)

Patient Problems No Consequences Or Impact To Patient (2199); Discharge (2225)

Event Date 10/04/2017

Event Type  malfunction  

Event Description

Ous mdr- the panera leo balloon was inflated up to 20 atm to treat a severely calcified lesion with a stenosis degree of 95% in the lad, when suddenly a loss of pressure was noticed.The patient is an (b)(6) male.

Manufacturer Narrative

It was intended to treat a severe calcified lesion (stenosis degree 95%) in the proximal lad.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 obviously been inflated.However, microscopic inspection revealed a pinhole in the proximal part of the balloons and scratches in the balloon surface were observed nearby.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 related root cause was determined.The final root cause for the reported event is most likely related to the severe calcification of the vessel.

• Brand Name: PANTERA LEO 2.5/20
• 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: 7018112
• MDR Text Key: 92211538
• Report Number: 1028232-2017-04126
• 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: 11/08/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 367026
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08161361
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2016
• 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