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

Catalog Number CQ75104

Device Problems Burst Container or Vessel (1074); Product Quality Problem (1506); Retraction Problem (1536)

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

Event Date 06/24/2014

Event Type  malfunction  

Event Description

It was reported that a break was identified in the balloon catheter during its initial inflation and was difficult to retract through the sheath.Another balloon dilation catheter 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 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.This is the only complaint reported to date for this lot number for this failure mode.The device was returned.The investigation is confirmed for a shaft burst, as a shaft burst, which was identified during the evaluation.The investigation is confirmed for retraction difficulty, based upon the condition in which the sample was returned (i.E.Prolapsed balloon material and flared introducer sheath tip).It is possible that the glue bullet was lodged within the catheter shaft and was blocking the inflation / deflation port during the initial inflation attempt.This could possibly cause the outer catheter shaft to burst and result in retraction difficulty.As the blue bullet appeared to be formed correctly.It is unk how it became partially lodged in the outer catheter shaft.The definitive root cause for the catheter shaft burst and the retraction difficulty is unk.The current ifu (instructions for use) states warnings: 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 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.Do not exceed the rbp recommended for this device balloon rupture may occur if the rbp rating is exceeded.To prevent over pressurization, use of a pressure monitoring device is recommended.Additionally, precautions and specific directions for use of the conquest pta dilation catheter are included in the ifu.

Event Description

It was reported that the pta balloon could not hold pressure during the initial inflation in a basilic vein a-v fistula, and subsequently the balloon could not be retracted through the introducer sheath.Upon removal, a crack was identified on the catheter shaft.Another balloon was used to complete the procedure.There was no reported patient injury.

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 report source 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: 4030899
• MDR Text Key: 4845794
• Report Number: 2020394-2014-00330
• 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,Followup
• Report Date: 06/25/2014

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 Catalogue Number: CQ75104
• Device Lot Number: REUC0862
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 07/18/2014
• Supplement Dates Manufacturer Received: 07/27/2014
• Supplement Dates FDA Received: 07/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1