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

Model Number	CQ5062
Medical Device Problem Codes	Difficult to Insert (1316); Peeled/Delaminated (1454); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for evaluation and two photos were provided for review.The investigation is confirmed for peeled pebax and unraveled material; however, the investigation is inconclusive for difficult to insert.A definitive root cause for the reported event could not be determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cq5062 pta balloon dilatation catheter allegedly experienced difficult to insert, unraveled material and peeled/delaminated.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) year old female patient is (b)(6) kgs.

• 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: 10737030
• Report Number: 2020394-2020-06086
• Device Sequence Number: 2113439
• Product Code: DQY
• UDI-Device Identifier: 00801741062865
• UDI-Public: (01)00801741062865
• 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): 10/26/2020

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: CQ5062
• Device Catalogue Number: CQ5062
• Device Lot Number: REDT3559
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/26/2020
• Patient Sequence Number: 1