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

Model Number CQ7594

Device Problems Deflation Problem (1149); Inflation Problem (1310); Material Rupture (1546); Detachment of Device or Device Component (2907)

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

Event Date 01/22/2021

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: 08/2023).

Event Description

It was reported that during an angioplasty procedure, the device allegedly had inflation and deflation problem.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 has been received for the evaluation.On the visual evaluation, the device appeared bloody and the proximal end of the balloon appeared pleated and folded while the distal end appeared to have been previously inflated.No other specific anomalies were noted.On the functional evaluation, the guidewire lumen was flushed and the water successfully exited out of the distal tip then the in-house guidewire has been inserted into the distal tip and the little resistance was felt at the kink but after maneuvering the guide wire was able to exited out of the guide wire luer.On further the balloon was then inflated using an in-house presto inflation device.It was noted the balloon was slow to inflate but nonetheless it inflated and held pressure then the balloon was deflated, the balloon takes nearly 57 seconds to deflate which is above the maximum deflation time of 35 seconds in product performance specification limit.Under the microscopic observation, the inflation holes were collapsed at the proximal glue joint and the glue bullet was not seated properly.No evidences were noted for the rupture and detachment on the device returned for the evaluation.Therefore the investigation for the identified inflation issue has been confirmed as the balloon was inflated slowly upon inflation during the functional evaluation.The investigation for the identified deflation issue has been confirmed as the balloon deflation time exceeds the product performance specification limit.The investigation for the reported balloon rupture has been unconfirmed as there is no evidence of rupture noted on the device returned for the evaluation.The investigation for the reported detachment of balloon has been unconfirmed as there is no detachment noted on the device returned for the evaluation.A definitive root cause could not be determined based upon the available 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: 08/2023), g3, h6 (method).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.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured and detached.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: 11730255
• MDR Text Key: 247456282
• Report Number: 2020394-2021-00920
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063190
• UDI-Public: (01)00801741063190
• 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: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CQ7594
• Device Catalogue Number: CQ7594
• Device Lot Number: REEW4537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other