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

Catalog Number	DR80610
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2016
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.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 investigation is inconclusive, as the sample was not returned for evaluation.The definitive root cause for the reported issue could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the current ifu (instructions for use) states: warnings: do not exceed the rbp recommended for this device.Balloon rupture may occur if the rbp rating is exceeded.To prevent over pressurization, use of a pressure monitoring device is recommended.Use: position the balloon relative to the lesion to be dilated, ensure the guidewire is in place and inflate the balloon to the appropriate pressure.Apply negative pressure to fully evacuate fluid from the balloon.Confirm that the balloon is fully deflated under fluoroscopy and that no contrast is left in the balloon.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 the vascular access intervention therapy for stenosis near the anastomotic part of the arteriovenous fistula in the forearm, the health care provider inserted the device from the anastomotic part to the central side of the artery, and inflated the balloon at the position where the balloon tip entered the artery from the anastomotic part.After the dilation was successfully performed at 22 atm, an unusual noise was allegedly heard thirty seconds after inflating the balloon.Reportedly, the device was removed from the patient's body and tested for deficiencies.Leakage and balloon damage was allegedly observed on the pta balloon.There was no reported patient injury.

• Brand Name: DORADO PTA BALLOON 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: 6984298
• Report Number: 2020394-2017-01455
• Device Sequence Number: 1227765
• Product Code: DQY
• UDI-Device Identifier: 00801741058837
• UDI-Public: (01)00801741058837
• 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
• Report Date (Section B): 10/27/2017

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: 01/31/2019
• Device Catalogue Number: DR80610
• Device Lot Number: 93NA0055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2016
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1