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

Model Number	CQ7594
Medical Device Problem Codes	Deflation Problem (1149); Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model cq7594 allegedly had deflation issues, retraction issues, and material rupture.This report was received from one source.The device was used inside the (b)(6) old male patient, of (b)(6) kgs.There was no reported patient injury.
Additional Manufacturer Narrative
Of the one reported event, the lot number was provided and a lot history review was performed.The device was returned for evaluation.A visual inspection found a burst in the catheter shaft.No signs of rupture were noted to the balloon.Therefore, the investigation confirmed for a burst shaft.The investigation is inconclusive for the reported deflation issue and retraction issue as the device was unable to be fully functional tested due to the burst.A definitive root cause could not be determined.The device is labeled for single use.(b)(4).
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model cq7594 allegedly had deflation issues, retraction issues, and material rupture.This report was received from one source.The device was used inside the fifty-seven year-old male patient, of 78 kgs.There was no reported patient injury.

• Brand Name: CONQUEST PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8511917
• Report Number: 2020394-2019-00279
• Device Sequence Number: 19248470
• Product Code: DQY
• UDI-Device Identifier: 00801741063190
• UDI-Public: (01)00801741063190
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: CQ7594
• Device Catalogue Number: CQ7594
• Device Lot Number: RECX1312
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 07/25/2019
• Patient Sequence Number: 1