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

Catalog Number CQ75104

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2015

Event Type  Injury  

Event Description

It was reported that the pta balloon only partially inflated and then would not deflate.A needle was inserted through the skin to deflate the balloon and the catheter was retracted without incident.There was no known impact or consequence to patient.

Manufacturer Narrative

A manufacturing review was performed.The lot met all release criteria.The device was returned.The investigation is inconclusive for deflation issues, as the balloon was unable to be inflated due to the glue bullet blocking the inflation/deflation port.The investigation is confirmed for inflation issues, as the balloon was unable to be inflated due to the glue bullet blocking the inflation/deflation ports.The investigation is confirmed for a product quality issue, as the od of the glue bullet was too small, causing the glue bullet to become lodged within the outer catheter shaft.The evaluation found the glue bullet was lodged within the catheter shaft, blocking the inflation/deflation ports.The od of the glue bullet was too small and did not meet the minimum required specification.The root cause for thee glue bullet becoming lodged in the catheter shaft is manufacturing related and likely caused the inflation/deflation issues.

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 weight and relevant history 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: 4585135
• MDR Text Key: 5480969
• Report Number: 2020394-2015-00118
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2015

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 Catalogue Number: CQ75104
• Device Lot Number: REYF0005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/13/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/04/2015
• Initial Date FDA Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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: 58 YR
• Patient Weight: 60