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

Model Number CQ7574

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

Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)

Event Date 01/14/2019

Event Type  Injury  

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: 09/2021).

Event Description

It was reported that during an angioplasty procedure in the axillary vein, the pta balloon allegedly had deflation issues.The health care provider reportedly cut the catheter outside the patient, in an attempt to deflate the balloon.A needle stick was used to deflate the balloon.Neither attempts at deflating the balloon were successful.The health care provided then opened the vessel to remove the balloon.The vessel was sutured and no further treatment was needed.The patient had no further complications.

Event Description

It was reported that during an angioplasty procedure in the axillary vein, the pta balloon allegedly had deflation issues.The health care provider reportedly cut the catheter outside the patient, in an attempt to deflate the balloon.A needle stick was used to deflate the balloon.Neither attempts at deflating the balloon were successful.The health care provided then opened the vessel to remove the balloon.The vessel was sutured and no further treatment was needed.The patient had no further complications.

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 in two segments.A visual inspection found a complete cut in the catheter shaft, resulting in the two segments.Stretching of the outer catheter shaft was noted, indicating retraction issues.Therefore, the investigation is confirmed for retraction issues.The distal segment was connected to a touhy-borst adapter and an inflation attempt was made.The stretching prevented the device from being inflated.Therefore, the investigation is inconclusive for the reported deflation issue, as the device was unable to be functionally tested due to the stretching in the catheter shaft.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.(expiry date: 09/2021).(patient code 2199 - removed).

• 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: 8326414
• MDR Text Key: 135736935
• Report Number: 2020394-2019-00116
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062995
• UDI-Public: (01)00801741062995
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CQ7574
• Device Catalogue Number: CQ7574
• Device Lot Number: RECW0324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Date Manufacturer Received: 04/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention