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

Model Number CQ7584

Device Problem Deflation Problem (1149)

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

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record 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: 05/2023).

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly had a deflation issue.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly had a deflation issue.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a device history record (dhr) review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one conquest pta dilatation catheter has returned for evaluation.On the visual evaluation of the device, it appeared bloody, no kink nor damage noted, and no specific anomalies noted.During the functional evaluation of the device, the guide-wire lumen has flushed, and in-house guide-wire inserted without any issue.An in-house presto inflation device inflate the balloon and hold pressure at 8 atm.On deflation the balloon took one minute and two seconds to deflect fully.Under microscopic observation of inflated balloon, it has noted that the inflation ports were found to be collapsed.On cutting the balloon for further observation it has founded that the glue bullet was pulled back and not seated correctly.Therefore, the reported deflation issue is confirmed for as the balloon deflated slowly and was noted to have a prolonged deflation time.The prolapsed inflation portion and the pulled glue bullet may have contributed to the reported deflation issue.However, the definitive root cause for the alleged deflation 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.H11: section a through f ¿ the information provide by bd represents all 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.H3 other text: see h10.

• 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: 10910417
• MDR Text Key: 218700897
• Report Number: 2020394-2020-20632
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• 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: REET2225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other