MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE FLOW DILATATION CATHETER; VALVULOPLASTY BALLOON CATHETER

Catalog Number UNK TRUE FLOW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Myocardial Infarction (1969); Renal Failure (2041)

Event Date 10/17/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal article citation: schneeberger, y., schaefer, a., schofer, n., silaschi, m., deuschl, f., blankenberg, s., ¿ conradi, l.(2018, october 18).Transcatheter aortic valve implantation utilizing a non-occlusive balloon for predilatation.Retrieved from https://www.Sciencedirect.Com/science/article/pii/s0167527318330791.

Event Description

It was reported in an article from the international journal of cardiology, titled " transcatheter aortic valve implantation utilizing a non-occlusive balloon for predilatation " that balloon aortic valvuloplasty (bav) was performed preceding transcatheter aortic valve implantation (tavi) in 27 patients.In one patient periprocedural myocardial infarction became apparent due to dissection of the left anterior descending artery.Acute renal failure necessitating renal replacement and major access site complications occurred in one patient respectively.A postprocedural permanent pacemaker (ppm) implantation due to atrioventricular blockade (avb) was indicated in 2 patients.The status of the patients was not provided.

• Brand Name: TRUE FLOW DILATATION CATHETER
• Type of Device: VALVULOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9485041
• MDR Text Key: 174556501
• Report Number: 2020394-2019-05661
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K172932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK TRUE FLOW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention