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

Catalog Number CQ7584

Device Problems Deflation Problem (1149); Inflation Problem (1310); Product Quality Problem (1506)

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

Event Date 03/25/2014

Event Type  Injury  

Event Description

It was reported that the pta balloon was difficult to inflate in a venous anastomosis between a graft and the native vein, however, the balloon did inflate and successfully opened the blockage.After inflation, the balloon would not deflate.The needle was inserted through the skin to deflate the balloon, and the catheter was then able to be retracted though the sheath without further incident.There was no reported pt injury.

Manufacturer Narrative

The lot number for the device has been provided.A review of the device history record is currently being performed.The device has been returned to mfr for eval.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.The balloon was stripped and cut at the proximal cone to examine the inflation/deflation lumens after opening the balloon, a bulge in the catheter at the location of the inflation/deflation port hole was observed.The catheter was cut longitudinally at the inflation/deflation port hole and it was noted that the glue bullet had become lodged within the catheter, blocking the inflation/deflation ports and preventing the balloon from inflating.Based on these results, the investigation is confirmed for inflation issues, however, the investigation is inconclusive for deflation issues, as the balloon could not be inflated due to the glue bullet being lodged in the outlet shalt.The root cause for the inflation and deflation issues is related to the glue bullet becoming lodged within the catheter shaft.Additionally, the glue 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.Operator awareness training regarding the glue bullet process was performed.The current ifu (instructions for use) states - when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or balloon separation.Additionally, specific directions for the use of the conquest balloon and potential adverse reactions are included in the ifu.

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 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 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 was able to provide new patient information, which was updated in the appropriate sections.

• 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: 3815445
• MDR Text Key: 4497830
• Report Number: 2020394-2014-00183
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/27/2014

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?: Yes
• Date Returned to Manufacturer: 04/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/22/2014
• Supplement Dates Manufacturer Received: 07/16/2014; 09/24/2015; 09/24/2015; 09/24/2015
• Supplement Dates FDA Received: 07/16/2014; 09/09/2014; 03/11/2015; 10/08/2015
• 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
• Patient Age: 71 YR
• Patient Weight: 91