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

Catalog Number UNKNOWN TRUE

Device Problems Break (1069); Deflation Problem (1149); Failure to Fold (1255); Retraction Problem (1536)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/11/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.Two fluoroscopic images and six photos are provided and reviewed.The first image (1a) shows a 24-mm true balloon inflated inside the 27-mm mosaic valve.The second image (1b) shows a femoral venogram demonstrating a filling defect in the right common iliac vein.The third photo (1c) shows the surgical view of the degloved true balloon in the right common iliac vein.The fourth photo (1d) shows the true balloon had been degloved and separated from the shaft of the balloon catheter.The fifth photo (2a) shows a true balloon inflated on a straight segment of wire.The sixth photo (2b) shows complete balloon rewrap on the straight segment of wire.The seventh photo (2c) shows a true balloon inflated on a curved segment of wire.The eighth photo (2d) shows incomplete balloon rewrap when deflated on a curved portion of the wire.The investigation is confirmed for the reported break as photos 1b, 1c and 1d show the break noted on the balloon.The investigation is also confirmed for the reported failure to fold and deflation problem as photo 2d shows the balloon not deflating to the correct folded profile.The investigation is also confirmed for the reported retraction problem as the break in the balloon would lead to difficulty removing the device.A definitive root cause for the alleged break, deflation problem, retraction problem and failure to fold could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Andrew g.Chatfield, mariama akodad, david meier, ming-yu (anthony) chuang, janarthanan sathananthan, david a.Wood, et.Al (2022).Failure of complete rewrap of a noncompliant valvuloplasty balloon complicating a transcatheter valve-in-valve procedure.Journal of the american college of cardiology, 15 (7): e81-e83.Doi: https://doi.Org/10.1016/j.Jcin.2022.02.020.Device not returned.

Event Description

It was reported in an article titled "failure of complete rewrap of a noncompliant valvuloplasty balloon complicating a transcatheter valve-in-valve procedure" that predilation of a transcatheter heart valve (thv) during a valvuloplasty procedure in the right common iliac vein, the valvuloplasty balloon allegedly failed to deflate and failed to fold.It was further reported that the valvuloplasty balloon allegedly would not retract and was partially degloved from the catheter shaft.Reportedly the balloon was removed by vascular surgery.The current status of the patient is not provided.

• Brand Name: TRUE DILATATION CATHETER
• Type of Device: BALLOON VALVULOPLASTY 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 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14942021
• MDR Text Key: 295406383
• Report Number: 2020394-2022-00541
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K150667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN TRUE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• 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): Required Intervention
• Patient Sex: Female