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

Model Number	CQ5084
Medical Device Problem Codes	Peeled/Delaminated (1454); Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 upon removal of a pta balloon dilatation catheter, balloon fibers were found allegedly peeled.Reportedly, upon pulling of the fibers, a slit was allegedly discovered.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 and two electronic photos were returned for evaluation.A visual inspection found peeled pebax on the balloon, with a portion of the pebax detached from the device.Therefore, the investigation is confirmed for peeled pebax.A diagonal cut was noted in the balloon, through both the fibers and balloon material.The cut did not extend through the entire balloon diameter, and the inner guidewire lumen was not cut.Therefore, the investigation is confirmed for a cut in the balloon material.However, the investigation is inconclusive for the reported rupture as the balloon was not able to be inflated due to the cut.Additionally, the investigation is inconclusive for the reported retraction issue, as the device was unable to be functionally tested.It is unlikely that the identified cut in the balloon is manufacturing related.During manufacturing, all catheters are 100% inspected and leak tested at pressure check.All catheters were folded and normalized and sampled at qc for visual and operational defects.The definitive root cause for the identified issues could not be determined based upon 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.(b)(4).
Event or Problem Description
It was reported that upon removal of a pta balloon dilatation catheter, balloon fibers were found allegedly peeled.Reportedly, upon pulling of the fibers, a slit was allegedly discovered.There was no reported patient injury.

• Brand Name: CONQUEST PTA BALLOON 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: 7474683
• Report Number: 2020394-2018-00520
• Device Sequence Number: 157769
• Product Code: DQY
• UDI-Device Identifier: 00801741063060
• UDI-Public: (01)00801741063060
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2018

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: CQ5084
• Device Catalogue Number: CQ5084J
• Device Lot Number: REBW1854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1