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); Incorrect, Inadequate or Imprecise Result or Readings (1535); Retraction Problem (1536)

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

Event Type  malfunction  

Event Description

It was reported that the pta balloon would not retract through the sheath.The balloon catheter and sheath were removed together as a single unit.Another balloon was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

A manufacturing review could not be performed as the lot number is unknown.The device has been returned to the manufacturer for evaluation.The investigation is currently underway.

Manufacturer Narrative

The device was returned lodged within an unknown introducer sheath.The patency of the guidewire lumen was tested using an in-house 0 035" guidewire and it passed without issue.The balloon was unable to be retracted from the introducer sheath.The balloon was able to advance through the introducer sheath.The balloon was then inflated with water using an in-house inflation device.The balloon was inflated to rpb (27atm) without issue; however, the balloon was unable to be deflated.The balloon was stripped and cut at the proximal cone to examine the inflation / deflation port.The catheter was cut longitudinally at the inflation/deflation port hole and it was noted that the glue bullet had become dislodged from the polyimide tubing and was lodged within the outer catheter, blocking the inflation / deflation port.Based on these results, the investigation is confirmed for retraction issues, the investigation is confirmed for deflation issues and the investigation is confirmed for a product quality issue, as the glue bullet was found to be lodged within the outer catheter shaft.The root cause for the deflation issues is related to the glue bullet becoming lodged within the catheter shaft, which led to the retraction issues.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 introducer sheath.Use of a gentle counterclockwise motion may be used to help facilitate catheter removal through the introducer sheath.

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.A follow-up attempt was 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 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: 4254785
• MDR Text Key: 5047331
• Report Number: 2020394-2014-00493
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2014

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: CQ7584
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/09/2014
• Initial Date FDA Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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