MAUDE Adverse Event Report: BIOTRONIK AG PANTERA LEO 3.0/15; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number 367017

Device Problem Failure to Deliver (2338)

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

Event Date 07/25/2017

Event Type  malfunction  

Event Description

Ous mdr - the device could not pass the severely calcified lesion in the medial lad.

Manufacturer Narrative

The physician reported that the complaint instrument could not cross a severely calcified lesion (85% stenosis degree, 3 mm vessel diameter).The technical investigation has shown that the balloon has been inflated.Therefore the folded profile could not be measured anymore.However, the folded profile of one piece per lot is assessed during lot release inspection and was found to be within specification.Review of the production documentation for the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations of the device being subject to this complaint, no material- or manufacturing related root cause was determined.Based on the information provided by the physician the remaining lumen diameter in the target lesion was smaller than the specified crossing profile of the complaint instrument.

• Brand Name: PANTERA LEO 3.0/15
• 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: 6777515
• MDR Text Key: 82166560
• Report Number: 1028232-2017-02812
• 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: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 367017
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10163287
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2016
• 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