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

Model Number	CQ5074
Medical Device Problem Codes	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
The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation identified peeling and unraveled material.Based upon the available information, the definitive root cause is unknown.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 cq5074 pta balloon dilatation catheter allegedly experienced peeling and unraveled material.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient¿s age, weight, and sex were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cq5074 pta balloon dilatation catheter allegedly experienced peeling and unraveled material.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient¿s age, weight, and sex were not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation confirmed for peeled/delaminated and removed code unraveled as material unraveled is covered under peeling code.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10:g4.H11: h6 (device code - 1664 - removed).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.

• 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: 9593572
• Report Number: 2020394-2020-00357
• Device Sequence Number: 595585
• Product Code: DQY
• UDI-Device Identifier: 00801741062957
• UDI-Public: (01)00801741062957
• 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): 04/06/2020

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: CQ5074
• Device Catalogue Number: CQ5074
• Device Lot Number: REBY2625
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 04/06/2020
• Patient Sequence Number: 1