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

Model Number	CQ75124
Medical Device Problem Codes	Difficult to Remove (1528); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided; therefore, a lot history review is currently being performed.The device was not returned to the manufacturer for evaluation.The investigation is inconclusive due to no sample return.The definitive root cause for the reported 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 difficult to remove.This information was received from one source.One patient was involved with no patient consequences.Age, weight, and sex were not provided.
Additional Manufacturer Narrative
H10: the lot number for the device was provided; therefore, a lot history review was performed.The device was not returned to the manufacturer for evaluation.The investigation was inconclusive for the reported retraction issue, as the device was not returned for evaluation.The definitive root cause for the reported retraction issue was unknown.The device is labeled for single use.H10: g1, g4.H11: 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.
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 difficult to remove and retraction problem.This information was received from one source.One patient was involved with no patient consequences.Age, weight, and sex were not provided.

• 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: 9967636
• Report Number: 2020394-2020-02824
• Device Sequence Number: 17102745
• 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): 07/13/2020

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: REDX2500
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/28/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 07/13/2020
• Patient Sequence Number: 1