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

Catalog Number	DR4054
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.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 the distal marker band of the balloon catheter allegedly could not be located.Reportedly, the health care provider completed the procedure with the same balloon catheter with some difficulty.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.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 event reported to date for this lot number and failure mode.Investigation summary: the investigation was inconclusive, as the sample was not returned for evaluation.The definitive root cause for the reported dislodged marker band could not be determined based upon available information.It was unknown whether patient and/or 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 the distal marker band of the balloon catheter allegedly could not be located.Reportedly, the health care provider completed the procedure with the same balloon catheter with some difficulty.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: 6894902
• Report Number: 2020394-2017-01221
• Device Sequence Number: 16308531
• Product Code: DQY
• UDI-Device Identifier: 00801741058486
• UDI-Public: (01)00801741058486
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018

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: 06/13/2020
• Device Catalogue Number: DR4054
• Device Lot Number: 93SB0222
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1