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

Catalog Number CQ7584

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

Patient Problems Thrombosis (2100); No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 02/19/2014

Event Type  Injury  

Event Description

It was reported that after an inflation in the axillary vein, the pta balloon could not be deflated.A needle was inserted through the skin to puncture and deflate the balloon; however, thrombus formed in the vessel.A thrombectomy was performed successfully.There was no reported adverse clinical consequence post-procedure.

Manufacturer Narrative

The device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.The lot met all release criteria.The investigation is inconclusive, as the sample was not returned for evaluation.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.

Manufacturer Narrative

The sample was returned for evaluation.A puncture was identified on the balloon approximately 3.5cm from the distal tip.Functional testing for deflation issues could not be performed due to the puncture.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).The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.

Manufacturer Narrative

The investigation is confirmed for a product quality issue, as the glue bullet was found to be improperly formed and lodged within the outer catheter shaft.The evaluation found the glue bullet lodged within the catheter shaft, partially blocking the inflation/deflation ports.Additionally, the glue bullet was improperly formed, 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 issue is unknown.Operator awareness training regarding the glue bullet process was performed.

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 international business representative 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: 3716126
• MDR Text Key: 4230968
• Report Number: 2020394-2014-00101
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2014

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 Expiration Date: 11/30/2016
• Device Catalogue Number: CQ7584
• Device Lot Number: REXJ2424
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/26/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2014
• Initial Date FDA Received: 03/21/2014
• Supplement Dates Manufacturer Received: 04/28/2014
• Supplement Dates FDA Received: 04/29/2014
• 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