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

Model Number	CQ5062
Medical Device Problem Codes	Peeled/Delaminated (1454); 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 review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
This report summarizes one (1) malfunction event.A review of the events indicated that model cq5062 pta balloon dilatation catheter, allegedly experienced a rupture.The procedure was completed with another device.This report was received from one source.This event involved one patient whose age, weight and gender was not provided.This patient had no reported patient injury.
Event or Problem Description
This report summarizes one (1) malfunction event.A review of the events indicated that model cq5062 pta balloon dilatation catheter, allegedly experienced a rupture.The procedure was completed with another device.This report was received from one source.This event involved one patient whose age, weight and gender was not provided.This patient had no reported patient injury.
Additional Manufacturer Narrative
The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.The device was returned for evaluation.A visual inspection found peeling throughout the length of the balloon.The device was inflated and water was seen exiting from a longitudinal rupture on the distal cone.Therefore, the investigation is confirmed for peeling and for a longitudinal rupture.The definitive root cause for the identified peeling and longitudinal rupture could not be determined based upon the available information.The device is labeled for single use.

• 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: 8516329
• Report Number: 2020394-2019-00322
• Device Sequence Number: 2798752
• 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,Followup
• Report Date (Section B): 07/25/2019

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: RECS2085
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 07/25/2019
• Patient Sequence Number: 1