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

Catalog Number CQ7588

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); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2014

Event Type  Injury  

Event Description

It was reported that during pre-dilatation of the track for a tips stent, the pta balloon would not deflate after the first inflation to nominal pressure.A needle was inserted percutaneously through the liver to deflate the balloon.There was no reported retraction difficulty through the sheath.Another balloon was used to complete 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 not been returned to the manufacturer for evaluation.The investigation is currently underway.

Event Description

It was reported that during pre-dilatation of a vessel for a tips procedure, prior to stent placement, the pta balloon would not deflate after the first inflation to nominal pressure.A needle was inserted percutaneously through the liver to deflate the balloon.There was no reported retraction difficulty through the sheath.Another balloon was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

The lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device was returned.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 proximal portion of catheter was not returned).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.Per the reported event, the conquest balloon was used during a tips procedure.The instructions for use (ifu) does not recommend the use within the liver vasculature.Per the ifu "conquest pta balloon dilatation catheter is recommended for use in percutaneous transluminal angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.This device is also recommended for post-dilatation of stent grafts in the peripheral vasculature." the evaluation found the glue bullet was lodged within the outer catheter shaft, blocking the inflation / deflation ports.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.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 due to the poor sample condition.Therefore, the definitive root cause for the deflation issues is unk.

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 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
• Type of Device: DQY
• 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: 4264098
• MDR Text Key: 5033700
• Report Number: 2020394-2014-00449
• 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
• Report Date: 09/17/2014

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: 04/30/2017
• Device Catalogue Number: CQ7588
• Device Lot Number: REYC2587
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/10/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/17/2014
• Initial Date FDA Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 113 KG