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

Model Number 393308

Device Problem Deflation Problem (1149)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 09/12/2017

Event Type  Death  

Event Description

Ous mdr.Affected balloon used for pre-dilatation of a lad stenosis prox.(80%) to mid (90%).The balloon was inflated up to 12 atm.During the procedure deflation of the balloon was not possible.The inflated balloon was removed.Further treatment performed: stenting lad mid to distal lad, & prox.Lad & main stem.The patient was an (b)(6) year old male.

Manufacturer Narrative

Since the device was not provided for investigation until today 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.Further, the provided angiographic material and cath lab report were reviewed.The provided angiographic material shows a balloon inflation in the medial to distal lad as also described in the cath lab report.Further a deflated balloon is visible in the target lesion.In the next sequence of images it is shown that a balloon is inflated inside the lesion with some air in the distal balloon lumen.The next sequence shows the still inflated balloon being located at the distal end of the guiding catheter.The review of the angiographic material and cath lab report did not lead to any further information regarding the nature of the complaint.Review of the manufacturing history of the product detailed above did not reveal any non-conformity.In addition to visual inspections each instrument is inflated before balloon folding during manufacturing.The device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection.

• Brand Name: PANTERA PRO 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: 6886178
• MDR Text Key: 87014718
• Report Number: 1028232-2017-03399
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K160985
• 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: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Model Number: 393308
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06175116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2017
• 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
• Patient Outcome(s): Death