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

Model Number CQ7584

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

Patient Problem Death (1802)

Event Date 01/10/2019

Event Type  Death  

Manufacturer Narrative

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: 09/2021).

Event Description

It was reported that during an angioplasty procedure in the basilic vein, the pta balloon allegedly could not be deflated.A needle stick was used to puncture the balloon through the skin to deflate.It was further reported that the device was difficult to remove from the patient.The graft was damaged as a result, and replaced.Another device was used to complete the procedure.It was further reported that four days post procedure, the patient expired.The cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.

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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection found the catheter shaft stretched along its length, indicating retraction issues.The stretching to the shaft had collapsed the inflation lumen preventing the device from being functionally tested.The balloon was returned partially deflated and bunched at the distal end.Dried contrast was noted within the balloon lumen, indicating the device was not fully deflated.Therefore, the investigation is confirmed for the reported deflation issue.The device was returned inserted through the user's introducer sheath.The distal end of the sheath was noted to be damaged, and the sheath was noted to be slightly buckled, indicating retraction issues.Based on the stretching to the catheter shaft and damage to the user's returned introducer sheath, the investigation is confirmed for retraction issues through the sheath.It is possible that the identified deflation issue could have contributed to the retraction issues through the sheath.However, it is unknown if the retraction issues and subsequent collapsing of the inflation lumen contributed to the deflation issue.The definitive root cause for the identified deflation and retraction issues could not be determined based on the available information.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.

Event Description

It was reported that during an angioplasty procedure in the basilic vein, the pta balloon allegedly could not be deflated.A needle stick was used to puncture the balloon through the skin to deflate.It was further reported that the device was difficult to remove from the patient.The graft was damaged as a result, and replaced.Another device was used to complete the procedure.It was further reported that four days post procedure, the patient expired.The cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.

• 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: 8317309
• MDR Text Key: 135424527
• Report Number: 2020394-2019-00109
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

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: RECX0945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 04/27/2019
• Supplement Dates FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death