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

Model Number	CQ7588
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or 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.
Event or Problem Description
It was reported that during an angioplasty procedure of an upper arm fistula, the pta balloon was allegedly coming apart and could not be removed from the sheath.Another pta balloon was used to successfully complete the procedure.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.The device was returned for evaluation.A visual inspection found the device returned stuck in the user's introducer sheath.A complete circumferential break was noted in the catheter shaft just proximal to the proximal balloon joint.Stretching was noted on the catheter shaft.Therefore, the investigation is confirmed for a break in the shaft and for sheath related retraction issues.The investigation is unconfirmed for detachment, as the inner guidewire lumen was still intact.It is possible that the user perceived the break as a detachment.It is likely retraction issues led to the catheter break.However, the definitive root cause for the retraction issue could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 10/2020).(b)(4).
Event or Problem Description
It was reported that during an angioplasty procedure of an upper arm fistula, the pta balloon was allegedly coming apart and could not be removed from the sheath.Another pta balloon was used to successfully complete the procedure.There was no reported patient injury.

• Brand Name: CONQUEST 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: 7640035
• Report Number: 2020394-2018-00994
• Device Sequence Number: 1556042
• Product Code: DQY
• UDI-Device Identifier: 00801741063138
• UDI-Public: (01)00801741063138
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/19/2018

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 Model Number: CQ7588
• Device Catalogue Number: CQ7588
• Device Lot Number: REBY1783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1