MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA 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
The lot number was provided and a lot history review will be performed.The return of the sample is pending.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of reported information indicated that model cq7584, pta dilatation catheter, allegedly experienced a break.This information was received from a single source.This malfunction did not involve a patient.The patient was a (b)(6) year-old male weighing (b)(6) lb.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review will be performed.The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is 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 reported information indicated that model cq7584, pta dilatation catheter, allegedly experienced a break.This information was recieved from a single source.This malfunction did not involve a patient.The patient was a 68 year-old male weighing 177 lb.
Event or Problem Description
This report summarizes one malfunction.A review of reported information indicated that model cq7584, pta dilatation catheter, allegedly experienced a break.This information was received from a single source.This malfunction did not involve a patient.The patient was a 68 year-old male weighing 177 lb.
Additional Manufacturer Narrative
H10: the lot number was provided; therefore, a lot history review was performed.The sample was returned, and the investigation unconfirmed for the reported catheter shaft breaks.A definite root cause for the reported event could not be determined.The device was labeled for single use.H10: g4, g7.H11: g1, h6 (results, conclusion).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 DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9596003
• Report Number: 2020394-2020-00429
• Device Sequence Number: 2696527
• 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,Followup,Followup
• Report Date (Section B): 07/09/2020

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: CQ7584
• Device Lot Number: REDU0406
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/25/2020; 06/30/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 04/13/2020; 07/09/2020
• Patient Sequence Number: 1