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

Model Number	CQ7588
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, the cq7588 pta balloon dilatation catheter was returned to the manufacturer for evaluation.The investigation identified both product problems.The investigation was not able to determine a root cause.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the events indicated that model cq7588 pta balloon dilatation catheter experienced material rupture and a retraction problem.This report was received from one source.The device was used in the patient.There was no reported patient injury.
Additional Manufacturer Narrative
H10.A lot number was provided, and a lot history review was performed.For the reported event, the cq7588 pta balloon dilatation catheter and a photo were returned to the manufacturer for evaluation.The investigation confirmed retraction issue and break; however, material rupture was not identified.The investigation was not able to determine a root cause.The device was labeled for single use.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 events indicated that model cq7588 pta balloon dilatation catheter experienced material rupture, a retraction problem, and a break.This report was received from one source.The device was used in the patient.Patient age, weight, and gender were not provided.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: 8808385
• Report Number: 2020394-2019-01623
• Device Sequence Number: 320348
• Product Code: DQY
• UDI-Device Identifier: 00801741063138
• UDI-Public: (01)00801741063138
• 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): 10/17/2019

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: CQ7588
• Device Catalogue Number: CQ7588
• Device Lot Number: REDN2420
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 10/17/2019
• Patient Sequence Number: 1