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

Catalog Number	DR8044
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As a result of a retrospective review of events that occurred in (b)(6) and in accordance with 21 c.F.R.Part 803, this event was assessed and determined to be mdr reportable.No medical records or no medical images have been made available to the manufacturer; however a photo was provided.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.
Event or Problem Description
It was reported that during the angioplasty procedure for stenosis near an anastomotic site, the health care provider inflated the balloon to 20 atm with an inflation device and tried to keep the balloon inflated at that pressure for 3 minutes.Reportedly, after keeping the pressure at 20 atm for 5 seconds the inflation hub allegedly came off the catheter and the contrast medium spattered.Another balloon catheter was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
A manufacturing review was performed.The lot met all release criteria.This is the only complaint reported to date for this lot number and failure mode.The device was not returned, however two electronic photos were provided for review.The photo review did not identify a detachment of the inflation hub from the inflation lumen; additionally, adhesive was noted in the correct locations on the inflation hub.Therefore, based on the photo review the investigation is unconfirmed for the reported hub detachment.The definitive root cause for the reported detachment could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) states: warnings: if resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or balloon separation.Use of the dorado pta dilatation catheter: advance the catheter through the introducer sheath and over the wire to the site of inflation.If the stenosis cannot be crossed with the desired dilatation catheter, use a smaller diameter catheter to pre-dilate the lesion to facilitate passage of a more appropriately sized dilatation catheter.Position the balloon relative to the lesion to be dilated, ensure the guidewire is in place and inflate the balloon to the appropriate pressure.
Event or Problem Description
It was reported that during the angioplasty procedure for stenosis near an anastomotic site, the health care provider inflated the balloon to 20 atm with an inflation device and tried to keep the balloon inflated at that pressure for 3 minutes.Reportedly, after keeping the pressure at 20 atm for 5 seconds the inflation hub allegedly came off the catheter and the contrast medium spattered.Another balloon catheter was used to complete the procedure.There was no reported patient injury.

• Brand Name: DORADO PTA DILATATION CATHETER
• Common Device Name: PTA DILATATION BALLOON CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6873013
• Report Number: 2020394-2017-01159
• Device Sequence Number: 16278210
• Product Code: DQY
• UDI-Device Identifier: 00801741058301
• UDI-Public: (01)00801741058301
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072283
• 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): 11/07/2017

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: 08/31/2017
• Device Catalogue Number: DR8044
• Device Lot Number: 93GY0254
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2016
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR