MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA BALLOON DILATION 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 Type  Injury  

Event Description

It was reported that the pta balloon would not deflate after an inflation in the subclavian vein.A needle was inserted through the skin to deflate the balloon and the catheter was retracted without incident.There was no reported patient injury.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 not been returned tot he manufacturer for evaluation.The investigation is currently underway.

Manufacturer Narrative

The lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.This is the only complaint reported for this lot number and issue to date.The returned device was attached to an inflation device.Attempts were made to inflate and deflate the device, however, these attempts were unsuccessful.The balloon was cut open at the proximal end to reveal the inflation/deflation lumen.The evaluation found the glue bullet was lodged within the catheter shaft, partially blocking the inflation/deflation ports.Additionally, the glue bullet appeared undersized, which likely contributed to it becoming lodged.Based on these results, the investigation is confirmed for deflation issues.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 root cause for the improperly formed glue bullet is manufacturing related.Operator awareness training regarding the glue bullet process was performed.The current ifu (instructions for use) states: use of the conquest pta dilatation catheter: apply negative pressure to fully evacuate fluid from the balloon.Confirm that the balloon is fully deflated under fluoroscopy.While maintaining negative pressure and the position of the guidewire, withdraw the deflated dilatation catheter over the wire through the withdraw the deflated dilatation catheter over the wire through the help facilitate catheter removal through the introducer sheath.

Manufacturer Narrative

A medical intervention was required to deflate the pta balloon with a needle stick through the skin.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 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 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 user facility did not have any additional details to provide at this time.

• Brand Name: CONQUEST PTA BALLOON DILATION 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: 4213278
• MDR Text Key: 4981227
• Report Number: 2020394-2014-00444
• 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
• Type of Report: Initial
• Report Date: 09/10/2014

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: 05/31/2017
• Device Catalogue Number: CQ75104
• Device Lot Number: REYE1418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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