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

Model Number	CQF75108
Medical Device Problem Codes	Entrapment of Device (1212); Inflation Problem (1310); Device Contamination with Chemical or Other Material (2944)
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.(b)(4).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cqf75108 pta dilatation catheter allegedly experienced entrapment of the device, inflation issues, retraction problems, material rupture, failure to advance and foreign material.This information was received from one source.One patient was involved with no patient consequences.The patient was a (b)(6) -year-old female who weighed (b)(6) pounds.
Additional Manufacturer Narrative
A lot history review was conducted, and it was determined that a device history record (dhr) review was not required.The device and a photo were received for evaluation.The investigation was confirmed for longitudinal rupture, inflation issue, material unraveling.A root cause has not been determined.The device is labeled for single use.Device code (1546, 2524).(device code: 1664 unraveled material, 1536 retraction problem; results, conclusion).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cqf75108 pta dilatation catheter allegedly experienced entrapment of the device, inflation issues, retraction problems, material rupture, failure to advance and foreign material.This information was received from one source.One patient was involved with no patient consequences.The patient was a 71-year-old female who weighed 166 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: 8823498
• Report Number: 2020394-2019-01823
• Device Sequence Number: 2839081
• Product Code: DQY
• UDI-Device Identifier: 00801741060649
• UDI-Public: (01)00801741060649
• 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): 10/10/2019

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: CQF75108
• Device Catalogue Number: CQF75108
• Device Lot Number: RECX4047
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 10/10/2019
• Patient Sequence Number: 1