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

Model Number	CQ75124
Medical Device Problem Codes	Material Frayed (1262); Inflation Problem (1310); Material Rupture (1546)
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 manufacturing review was performed.The sample was returned to the manufacturer for evaluation.Therefore, the investigation of the reported event is confirmed for the frayed material, identified longitudinal balloon rupture and unconfirmed for the reported inflation issue.Based upon the available information, the definitive root cause for this event 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 cq75124 pta balloon dilatation catheter allegedly experienced inflation issue, frayed and longitudinal rupture.This information was received from one source.The malfunction had patient involvement but the patient had no consequences.The patient was a (b)(6) year old female weighing (b)(6) lbs.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cq75124 pta balloon dilatation catheter allegedly experienced inflation issue, frayed and longitudinal rupture.This information was received from one source.The malfunction had patient involvement but the patient had no consequences.The patient was a 62 year old female weighing 185 lbs.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a manufacturing review was performed.The sample was returned to the manufacturer for evaluation.Therefore, the investigation of the reported event is confirmed for the frayed material, identified longitudinal balloon rupture and unconfirmed for the reported inflation issue.Based upon the available information, the definitive root cause for this event is unknown.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.

• 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: 10279442
• Report Number: 2020394-2020-04465
• Device Sequence Number: 19464388
• Product Code: DQY
• UDI-Device Identifier: 00801741063251
• UDI-Public: (01)00801741063251
• 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): 07/20/2020

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: CQ75124
• Device Catalogue Number: CQ75124
• Device Lot Number: REDW0248
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 07/20/2020
• Patient Sequence Number: 1