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

Catalog Number	DR80610
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/24/2017
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.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 when flushing the device during preparation for an angioplasty procedure, an alleged leak was observed from the pta balloon catheter shaft.There was no patient contact.
Additional Manufacturer Narrative
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.The device was returned.A visual inspection found a partial break at the butt joint between the catheter and proximal end of the balloon.An inflation attempt was made and water was seen exiting the break.Therefore, the investigation is confirmed for the reported leak as well as for the identified break at the butt joint.The break at the glue butt joint resulted in the identified leak.However, the definitive root cause for the partial break 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.(b)(4).
Event or Problem Description
It was reported that when flushing the device during preparation for an angioplasty procedure, an alleged leak was observed from the pta balloon catheter shaft.There was no patient contact.

• Brand Name: DORADO PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7035979
• Report Number: 2020394-2017-01570
• Device Sequence Number: 1745098
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2017

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: 06/15/2020
• Device Catalogue Number: DR80610
• Device Lot Number: 93SB0088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1