MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA BALLOON DILATATION CATHETER; DQY

Catalog Number CQ75124

Device Problems Deflation Problem (1149); Product Quality Problem (1506)

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

It was reported that the pta balloon would not inflate beyond 8 atm and then would not deflate.After manipulation, the balloon eventually deflated enough to be removed through the sheath.Another balloon was used to perform the procedure.There was no reported patient injury.

Manufacturer Narrative

The lot number for the device has been provided.A review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation is currently underway.

Manufacturer Narrative

The evaluation found the glue bullet was lodged within the catheter shaft partial blocking the inflation/deflation ports additionally, the glue bullet did not appear perpendicular to the polymide surface, which may have contributed to it becoming lodged.The root cause for the deflation issues is related to the glue bullet becoming lodged within the catheter shaft, which led to the retraction issues.The root cause for the improperly formed glue bullet is mfg related.Operator awareness training regarding the glue bullet process was performed.

Manufacturer Narrative

A voluntary recall was initiated on 3/23/2015.Bard peripheral vascular has confirmed that the product code and lot number identified to this event may be at risk of having deflation related issues in the event a pta balloon will not deflate, immediate intervention is required in order to deflate the balloon and allow for continued blood flow in many cases, this can be accomplished percutaneously by inserting a device to the pta balloon and puncturing the balloon and/or a sheath, allowing its withdrawal.

Manufacturer Narrative

To ensure compliance to 21 cfr 803.50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided.Multiple follow up attempts were made with the facility to obtain any information pertaining to the patient, product, and/or procedural details (e.G.Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation.The facility did not have any additional details to provide at this time.

• Brand Name: CONQUEST PTA BALLOON DILATATION CATHETER
• Type of Device: DQY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 4161757
• MDR Text Key: 4784325
• Report Number: 2020394-2014-00340
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: CQ75124
• Device Lot Number: REYC1426
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2014
• Initial Date FDA Received: 07/24/2014
• Supplement Dates Manufacturer Received: 08/21/2014
• Supplement Dates FDA Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1