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

Model Number CQF7588

Device Problems Deflation Problem (1149); Material Deformation (2976)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the device is pending.The investigation of the reported event is currently underway.(expiry date: 08/2022).

Event Description

It was reported that during an angioplasty procedure in the brachial artery, the pta balloon allegedly could not be fully deflated.It was further reported that a needle stick was used to percutaneously deflate the balloon.The balloon was removed from the patient and another device was used to complete the procedure.There were no further reported complications to the patient.

Manufacturer Narrative

H10: manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: the device was returned for evaluation.A visual inspection found bunching to the outer catheter shaft.Therefore, the investigation is confirmed for the identified outer catheter shaft bunching.Due to the condition of the returned device, functional testing was unable to be performed.Therefore, the investigation is inconclusive for the reported deflation issue.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 08/2022).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 in the brachial artery, the pta balloon allegedly could not be fully deflated.It was further reported that a needle stick was used to percutaneously deflate the balloon.The balloon was removed from the patient and another device was used to complete the procedure.There were no further reported complications to the patient.

• 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: 9914190
• MDR Text Key: 186593557
• Report Number: 2020394-2020-02249
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060571
• UDI-Public: (01)00801741060571
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CQF7588
• Device Catalogue Number: CQF7588
• Device Lot Number: REDW1358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 06/02/2020
• Supplement Dates FDA Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention