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

Model Number	CQ7582
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, 2 lot number were provided, and lot history review.The sample were returned for evaluation.The company is still investigating the issue at this time.Material separation was identified for the device.A root cause has not been determined.The device was labeled for single use.
Event or Problem Description
This report summarizes two malfunction.A review of the reported information indicated that model cq7582 pta balloon dilatation catheter allegedly experienced a break.This report was received from a single source.This malfunction did not involve patient with no patient contact.The patient is (b)(6) years of age, the gender is male, and the weight is (b)(6) lbs.

• 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: 9596207
• Report Number: 2020394-2020-00433
• Device Sequence Number: 2525637
• Product Code: DQY
• UDI-Device Identifier: 00801741063091
• UDI-Public: (01)00801741063091
• 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
• Report Date (Section B): 01/16/2020

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: CQ7582
• Device Catalogue Number: CQ7582
• Device Lot Number: REBV1769
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/16/2020
• Patient Sequence Number: 1