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

Model Number CQ7584

Device Problems Inflation Problem (1310); Retraction Problem (1536)

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

Event Date 04/23/2021

Event Type  malfunction  

Manufacturer Narrative

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: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the alleged balloon failure to inflate and retraction 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.(expiry date: 07/2023).

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to inflate.It was further reported that the device allegedly had a retraction problem.The procedure was completed by using another device.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 pta dilatation catheter was returned for evaluation.The returned sample appeared to be bloody.No other anomalies were noted to the sample.During functional testing, the returned device was attempted to inflate with an inhouse presto inflation device and the balloon failed to inflate.Then the catheter was cut and touchy adaptor was used to inflate the device, but was still unable to inflate the balloon.On further, the balloon was cut and examined under microscope.It was noted the glue bullet was noted to be inserted into the inner catheter and the port holes were collapsed.No further testing was performed.The investigation for the reported inflation issue can be confirmed, as the device was not able to be inflated during functional evaluation.The investigation for the reported retraction issue remains inconclusive, as functional testing cannot be reciprocated due to the condition of the device.The glue bullet withdrawn into the inflation lumen and the collapsing of the port holes is a possible cause of the reported inflation issue.A definitive root cause for the reported inflation issue and retraction issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 07/2023), g3.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 during an angioplasty procedure, the pta balloon allegedly failed to inflate.It was further reported that the device allegedly had retraction problem and the procedure was completed using another device.There was no reported patient injury.

• Brand Name: CONQUEST 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: 11893281
• MDR Text Key: 252931721
• Report Number: 2020394-2021-01122
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063114
• UDI-Public: (01)00801741063114
• Combination Product (y/n): N
• PMA/PMN Number: K083657
• 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: 07/19/2021

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 Model Number: CQ7584
• Device Catalogue Number: CQ7584
• Device Lot Number: REEV3423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other