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

Model Number	CQF7574
Medical Device Problem Codes	Deflation Problem (1149); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The results of the anticipated device evaluation will be provided upon completion of the event investigation.(expiry date 06/2021).
Event or Problem Description
It was reported that during an angioplasty procedure of a venous anastomosis the pta balloon allegedly ruptured.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure of a venous anastomosis the pta balloon allegedly had difficulty deflating.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.The device was prepped per the instructions for use, and inflated with a 10ml syringe.An in-house locking flow switch was also used during functional testing.The device was deflated within the specified time constraints, without any issues.Therefore, the investigation is unconfirmed for the reported deflation issue.The definitive root cause for the reported deflation issue could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• 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: 8224565
• Report Number: 2020394-2018-02287
• Device Sequence Number: 16209276
• Product Code: LIT
• UDI-Device Identifier: 00801741060496
• UDI-Public: (01)00801741060496
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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: Health Professional
• Device Model Number: CQF7574
• Device Catalogue Number: CQF7574
• Device Lot Number: RECU1982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 43