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

Catalog Number CQ75104

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 06/10/2014

Event Type  Injury  

Event Description

It was reported that after an inflation at 4atm, the pta balloon would not deflate.A needle was inserted through the skin to deflate the balloon and the catheter was retracted through the introducer sheath without incident.There was no reported patient injury.

Manufacturer Narrative

The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.The sample was returned for evaluation and found the glue bullet was lodged within the catheter shaft, partially blocking the inflation/deflation ports.Additionally, the glue b bullet did not appear perpendicular to the polyimide surface, which may have contributed to it becoming lodged.The root cause for the improperly formed glue bullet is manufacturing related.The root cause for the deflation issues is likely related to the glue bullet becoming lodged within the catheter shaft; however, the balloon could not be inflated and deflated during functional testing, as the balloon had been punctured by the user.Therefore, the definitive root cause for the deflation issues is unknown.Operator awareness training regarding the glue bullet process has been completed.The investigation is inconclusive for deflation issues as full functional testing could not be completed due to the condition in which the sample was returned (i.E.Balloon was punctured).

Manufacturer Narrative

A medical intervention was required to deflate the pta balloon with a needle stick percutaneously through the liver.There was no known impact or consequence to patient.After further clinical review of this event with bard's medical department, this event was reassessed and determined to be mdr reportable as a serious injury pursuant to 21 cfr part 803.

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 user 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 report source did not have any additional details to provide at this time.

• Brand Name: CONQUEST PTA BALLOON DILATATION CATHETER
• 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: 4008347
• MDR Text Key: 4691441
• Report Number: 2020394-2014-00310
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CQ75104
• Device Lot Number: REX11134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2014
• Initial Date FDA Received: 07/11/2014
• Supplement Dates Manufacturer Received: 08/20/2014
• Supplement Dates FDA Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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