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

Model Number	CQ7594
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the one reported event, the one device was returned to bd and evaluated.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model cq7594 pta balloon dilatation catheter allegedly ruptured prior to reaching 26atm.This report was received from one source.Of the one event, did involved patient with no reported patient injury.The patients age, weight and gender not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for the returned device, and a lot history review was performed.A pinhole rupture was observed for the device.A root cause has not been determined.The device was labeled for single use.H11: h6 (results 1).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 or Problem Description
This report summarizes one malfunction.A review of the event indicated that model cq7594 pta balloon dilatation catheter allegedly ruptured prior to reaching 26atm.This report was received from one source.The alleged malfunction involved a patient with no reported patient injury.The patients age, weight and gender not provided.

• 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: 8515478
• Report Number: 2020394-2019-00297
• Device Sequence Number: 1432510
• 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): 07/23/2019

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: RECP0915
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1