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

Model Number	CQ7588
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The one device belonging to the sole malfunction is expected to be returned to bd for evaluation.The company is still investigating the issue at this time.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 cq7588 pta balloon dilatation catheter allegedly experienced a retraction problem.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a (b)(6) year old female weighing 52 kgs.
Additional Manufacturer Narrative
H10: the one device belonging to the sole malfunction was returned to bd for evaluation.As the lot number was provided a lot history review will be performed.The investigation did not identify a retraction problem.A root cause could not be determined.The device is labeled for single use.H10: 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 cq7588 pta balloon dilatation catheter allegedly experienced a retraction problem.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a 65-year-old female weighing 52 kgs.

• 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: 9198341
• Report Number: 2020394-2019-04003
• Device Sequence Number: 11540027
• Product Code: DQY
• UDI-Device Identifier: 00801741063138
• UDI-Public: (01)00801741063138
• 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): 01/08/2020

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: CQ7588
• Device Catalogue Number: CQ7588
• Device Lot Number: REDR2106
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 01/08/2020
• Patient Sequence Number: 1