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

Model Number	CQF75102
Medical Device Problem Codes	Material Frayed (1262); Peeled/Delaminated (1454); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number of the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(b)(4).The information provided by bard 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 bard.
Event or Problem Description
It was reported that during a pta procedure the balloon allegedly ruptured.There was no reported patient injury.
Event or Problem Description
It was reported that during a pta procedure the balloon allegedly ruptured.There was no reported patient injury.
Additional Manufacturer Narrative
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.The device was returned for evaluation.A visual inspection found the device stuck in the user's introducer sheath.Stretching to the catheter shaft and damage to the introducer sheath were noted, and balloon material was seen folded over the distal tip of the device.Therefore, the investigation is confirmed for sheath related retraction issues.The sheath was able to be pulled back from the balloon, and frayed balloon fibers and peeled pebax were noted on the balloon material.Additionally, two longitudinal ruptures were noted to the balloon.Therefore, the investigation is confirmed for frayed fibers, peeled pebax, and for longitudinal ruptures.It is likely that the ruptures resulted in the identified retraction issues through the introducer sheath.However, the definitive root cause for the identified rupture and fiber and pebax issues could not be determined based on the available information.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: 7593152
• Report Number: 2020394-2018-00848
• Device Sequence Number: 2194771
• Product Code: LIT
• UDI-Device Identifier: 00801741060625
• UDI-Public: (01)00801741060625
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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 Expiration Date: 09/30/2020
• Device Model Number: CQF75102
• Device Catalogue Number: CQF75102
• Device Lot Number: REBW2105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1