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

Catalog Number CQF7584

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date: 09/2023.

Event Description

It was reported that post procedure through the subclavian vein, the device was allegedly difficult to deflate.It was further reported that after several attempts, the balloon was deflated.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event investigation summary: one conquest 40 pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device was noted bloody and the balloon was noted to be partially inflated.No other specific anomalies were noted.On the functional evaluation, the guidewire lumen was flushed and the water exited out of the distal tip successfully.The balloon remains partially inflated even after the negative pressure was applied using an in-house presto inflation device.Then the balloon was inflated using an in-house presto inflation device to a nominal pressure of 8 atm and the balloon remained partially inflated as well.In order to inflate the balloon, the catheter was cut and attached to the the touhy adapter while the catheter tip was clamped then the balloon inflated successfully and maintains the pressure.The balloon was then deflated and the deflation time was noted to be within th product performance specification limit.No further testing was performed.Therefore the investigation for the reported deflation issue was inconclusive as the balloon has a inflation issue and it was inflated only after the catheter was cut and attached to the adapter during the functional testing.The investigation for the identified inflation issue is confirmed for, as the balloon only partially inflated during the functional testing and the balloon only inflated fully after the catheter was cut and inflated with the touhy adapter.A definitive root cause for the reported deflation issue and the identified inflation issue could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 09/2023), g3, h6 (device and method) h11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that post procedure through the subclavian vein, the device was allegedly difficult to deflate.It was further reported that after several attempts, the balloon was deflated.There was no reported patient injury.

• 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
• MDR Report Key: 11395160
• MDR Text Key: 234218762
• Report Number: 2020394-2021-00386
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K120660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CQF7584
• Device Lot Number: REEX3023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR