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

Model Number CQ7584

Device Problems Deflation Problem (1149); Inflation Problem (1310); Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation of the reported event is currently underway.Medical device - expiry date: 04/2022.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly was difficult to inflate and had deflation issues which caused retraction problems.It was further reported that the balloon had to be punctured with a needle in order to be deflated and removed from the patient.Another pta balloon was used to complete the procedure.There was no reported complications to the patient.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly was difficult to inflate and had deflation issues which caused retraction problems.It was further reported that the balloon had to be punctured with a needle in order to be deflated and removed from the patient.Another pta balloon was used to complete the procedure.There was no 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 review was not required.Investigation summary: the device and one electronic photo were returned for evaluation.The photo shows the distal half of a pta balloon.The distal area of the balloon circled.The balloon appears to be slightly larger near the distal tip, but it is unable to be confirmed due to the quality of the photo.Based on the photo review, no confirmations can be made.A visual inspection was performed and no anomalies were noted to the device.The device was not inflated due to the user puncturing the balloon.The balloon was cut to expose the device inflation/deflation ports, and no anomalies were noted to the inflation/deflation ports.No further functional testing was performed.Therefore, the investigation is inconclusive for the reported inflation issue, deflation issue, and retraction issue, as the device was unable to be tested due to the user puncturing the balloon.It is possible the reported deflation issue contributed to the reported retraction issue.However, the definitive root cause for the reported inflation issue, deflation issue, and retraction issue could not be determined based upon available information.It is unknown whether patient or procedural issues contributed to the event.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.H11: h3, h6 (results, conclusion).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.

• 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: 9417113
• MDR Text Key: 169265250
• Report Number: 2020394-2019-05270
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

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: CQ7584
• Device Catalogue Number: CQ7584
• Device Lot Number: REDS4897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 02/28/2020
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention