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

Model Number	CQ7588
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to bd for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes five malfunctions.A review of the reported information indicated that model cq7588 pta balloon dilatation catheter allegedly experienced deflation issue and difficulty inflating.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information was not provided.
Additional Manufacturer Narrative
H10: the quantity affected of the malfunction was changed from 5 to 1.The lot number for the malfunction was not provided.The device has been returned for evaluation; the investigation is unconfirmed for difficult to deflate and inflation issue.Based upon the available information, the definitive root cause 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.
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 deflation issue and difficulty inflating.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information was 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: 9198425
• Report Number: 2020394-2019-04004
• Device Sequence Number: 18944707
• 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): 01/07/2020

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: UNKNOWN
• 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: 01/07/2020
• Patient Sequence Number: 1