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

Catalog Number	DR4074
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During a retrospective review of events processed through a recently acquired entity and in accordance with 21 c.F.R part 803, this record has been 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.Visual/microscopic inspection: the balloon size for this product is printed on the hub and identified the returned sample as a 7mm x 4cm balloon.Kinks were noted 4.4cm and 5.2cm form the distal tip.However after review of the preliminary pictures, the manner in which the device was packaged for return may have contributed to the kink.No kinks were reported by the user.No anomalies were noted along the length of the catheter.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0.035¿ guidewire, and the guidewire was unable to pass due to dried the kinks.The inflation hub was connected to a max30 inflation device and water was used to inflate the balloon.Upon inflation, water was observed leaking from the proximal glue joint.The device was examined under magnification (10x) and a partial circumferential catheter break was identified at the glue joint.The balloon was unable to be inflated to rbp due to the leak.The balloon was able to be deflated without issue.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: one electronic photo was reviewed by field assurance engineer.The photo shows the device laying coiled up on brown paper towels.The balloon appears to have been previously inflated.No visual anomalies were able to be seen on the balloon, catheter shaft, or luers.Based on the photo review, the reported leak could not be confirmed.Conclusion: the device and one photo were provided for review.The device was inflated and the water was seen exiting a break at the balloon glue joint, confirming the investigation for the reported inflation issue, and for a break.The root cause for the partial break at the proximal balloon glue joint could not be determined based upon available information.It is unknown whether patient and/or procedural factors 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.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 an angioplasty procedure, the pta balloon allegedly leaked from the proximal side once inflation pressure was provided.Another catheter was used to complete the procedure.There was no reported patient injury.

• Brand Name: DORADO 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: 6613295
• Report Number: 2020394-2017-00564
• Device Sequence Number: 10764962
• Product Code: DQY
• UDI-Device Identifier: 00801741058974
• UDI-Public: (01)00801741058974(17)190630(10)93TA0113
• 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): 06/05/2017

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: 06/30/2019
• Device Catalogue Number: DR4074
• Device Lot Number: 93TA0113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1