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

Model Number	CQF75104
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample has been returned to the company for evaluation.The company is still investigating the issue at this time.The devices are labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cqf75104, pta dilatation catheter, allegedly experienced a balloon rupture.This information was received from various sources.One patient was involved with no reported patient injury.The patient is male, (b)(6) years old, and (b)(6) pounds.
Additional Manufacturer Narrative
H10: for the reported malfunction, the lot number was provided and a lot history review was performed.The sample has been returned to the company for evaluation.After sample evaluation, the investigation was confirmed for material rupture.Based on the information provided, 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 cqf75104, pta dilatation catheter, allegedly experienced a balloon rupture.This information was received from one source.One patient was involved with no reported patient injury.The patient is male, 77 years old, and 165 pounds.

• Brand Name: CONQUEST 40 PTA DILATATION CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9198664
• Report Number: 2020394-2019-04010
• Device Sequence Number: 3031632
• Product Code: DQY
• UDI-Device Identifier: 00801741060632
• UDI-Public: (01)00801741060632
• 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: CQF75104
• Device Catalogue Number: CQF75104
• Device Lot Number: REDS1479
• 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