MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. CONQUEST PTA BALLOON DILATATION CATHETER

Model Number	CQ7588
Medical Device Problem Codes	Peeled/Delaminated (1454); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2018
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 not 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 after two inflations (25 atm each inflation) of a pta balloon catheter in the cephalic fistula, upon removal of the device, the health care provider allegedly identified unraveled balloon fibers.There was no difficulty retracting the balloon catheter through the sheath, there was no reported vessel trauma, and there were no stent(s) present in the vessel track or treatment site.Reportedly, another balloon catheter was used to complete the procedure.The patient was reported as doing well.
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.A visual inspection found the outer pebax layer to be partially peeled from balloon.No fiber disturbance or frayed was noted.Therefore, the investigation is unconfirmed for the reported unraveled fiber material, and confirmed for peeled pebax.It is likely that the user perceived the peeled pebax as unraveled fiber material.The definitive root cause for the identified peeled pebax could not be determined based upon available information.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.
Event or Problem Description
It was reported that after two inflations (25 atm each inflation) of a pta balloon catheter in the cephalic fistula, upon removal of the device, the health care provider allegedly identified unraveled balloon fibers.There was no difficulty retracting the balloon catheter through the sheath, there was no reported vessel trauma, and there were no stent(s) present in the vessel track or treatment site.Reportedly, another balloon catheter was used to complete the procedure.The patient was reported as doing well.

• Brand Name: CONQUEST PTA BALLOON DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• MDR Report Key: 7382362
• Report Number: 2020394-2018-00299
• Device Sequence Number: 11197733
• Product Code: DQY
• UDI-Device Identifier: 00801741063138
• UDI-Public: (01)00801741063138
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083657
• 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): 06/01/2018

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: 12/31/2020
• Device Model Number: CQ7588
• Device Catalogue Number: CQ7588
• Device Lot Number: REBZ1552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 59