MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number CQF7588

Device Problems Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

No device, no medical records, or no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that during preparation for an angioplasty procedure, a hole was found in the inner packaging sleeve.Another balloon was used to perform the procedure.There was no patient contact.

Manufacturer Narrative

The device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.The device was not returned, however one electronic photo was provided for review.Although a tear can be seen in the provided photo, it is unknown if a breach of the sterile barrier occurred as it cannot be verified if the sleeve shown has been opened.Additionally, the outer packaging is not visible, and cannot be reviewed for similar damage.Therefore, the investigation can be confirmed for a hole in the inner packaging sleeve.However, the investigation remains inconclusive for a breach of sterile barrier.It is unlikely that the root cause is manufacturing related as all packaged product manufactured is 100% verified for package integrity prior to shipment per spec.It is possible that shipping/handling or user related issues in opening the product packaging contributed to the event.However, the definitive root cause for the identified hole in the packaging sleeve could not be determined based upon the available information.Labeling review: the current instructions for use (ifu) states: warnings: contents supplied sterile using ethylene oxide (eo).Non-pyrogenic.Do not use if sterile barrier is opened or damaged.Single patient use only.Do not reuse, reprocess or re-sterilize.Precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.

Event Description

It was reported that during preparation for an angioplasty procedure, a hole was found in the inner packaging sleeve.Another balloon was used to perform the procedure.There was no patient contact.

• Brand Name: CONQUEST 40 PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 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 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7121576
• MDR Text Key: 95058423
• Report Number: 2020394-2017-01758
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060571
• UDI-Public: (01)00801741060571
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: CQF7588
• Device Catalogue Number: CQF7588
• Device Lot Number: REBX0481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2017
• 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