MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	CQF7588
Medical Device Problem Codes	Retraction Problem (1536); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned 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 cqf7588 pta balloon dilatation catheter allegedly experienced a retraction problem and unraveled material.There was no reported patient injury.This information was received from one source.The patient was a (b)(6) year-old male who weighed (b)(6) pounds.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.A visual inspection was performed and unraveling material was noted on the balloon.Therefore, the investigation is confirmed for the reported unraveled fibers, as unraveling material was noted on the balloon.The investigation is inconclusive for the reported retraction issue, as the device was unable to be tested further due to the condition of the device.The definitive root cause could not be determined.The device is labeled for single use.H11: g1, 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 cqf7588 pta balloon dilatation catheter allegedly experienced a retraction problem and unraveled material.There was no reported patient injury.This information was received from one source.The patient was a 46-year-old male who weighed 234 pounds.

• Brand Name: CONQUEST 40 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: 8813089
• Report Number: 2020394-2019-01688
• Device Sequence Number: 16858836
• Product Code: DQY
• UDI-Device Identifier: 00801741060571
• UDI-Public: (01)00801741060571
• 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): 10/09/2019

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: CQF7588
• Device Catalogue Number: CQF7588
• Device Lot Number: RECV3061
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1