MAUDE Adverse Event Report: C.R. BARD, INC. VASCUTRAK; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number V1870250

Device Problems Break (1069); Deflation Problem (1149)

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

Event Date 03/25/2016

Event Type  malfunction  

Event Description

At the end of right common iliac artery angiogram with intervention, the cardiac interventionist was ready to deflate the balloon and remove it from the patient's body, and the hub broke off of the balloon.The cardiac interventionist was able to use other tools to deflate the balloon and remove the balloon from the patient's body.No patient injury noted with procedure.Manufacturer response for dilatation catheter, vascutrak pta dilatation catheter (per site reporter): contacted customer service representative at bard vascular about event and return kit to be sent to our representative along with replacement product.The product involved in the event and packaging has been saved for manufacturer investigation and will be given to our bard sales representative on her next visit.

• Brand Name: VASCUTRAK
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): C.R. BARD, INC.; 1415 west 3rd street; suite 109; tempe AZ 85280
• MDR Report Key: 5587795
• MDR Text Key: 43132200
• Report Number: 5587795
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2016,04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/01/2018
• Device Catalogue Number: V1870250
• Device Lot Number: GFZD2712
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 63 YR
• Patient Weight: 99