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

Catalog Number	DR8084
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2017
Type of Reportable Event	Malfunction
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.Visual/microscopic inspection: the balloon size for this product is printed on the hub and identified the returned sample as a 5mm x 4cm balloon.A kink was noted 50.3cm from the glue joint.However after review of the preliminary pictures, the manner in which the device was packaged for return likely contributed to the kink.No kinks were reported by the user.No other 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 able to pass the two kinks in the device catheter.The inflation hub was connected to an in-house inflation device and water was used to inflate the balloon.Upon inflation, water was observed leaking from the glue joint.The device was examined under magnification (35x) and a partial circumferential catheter break was identified at the glue joint.The balloon was unable to be inflated to rated burst pressure due to the leak.The balloon was able to be deflated without issue.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was returned.An initial visual inspection did not find any leak related defects.However, an attempt was made to inflate the device, and a partial circumferential break was noted at the glue joint, confirming the investigation for the reported leak and for a break at the glue joint the root cause for the leak in the device was found to be a partial break at the proximal balloon butt joint.However, the definitive root cause for the break 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, two alleged leaks were observed on the pta balloon catheter.Reportedly, there was no issue retracting the balloon through the sheath.Another balloon was used to complete the procedure.There was no reported patient injury.

• 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: 6863867
• Report Number: 2020394-2017-01132
• Device Sequence Number: 16171990
• Product Code: DQY
• UDI-Device Identifier: 00801741059254
• UDI-Public: (01)00801741059254
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2017

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: 02/16/2020
• Device Catalogue Number: DR8084
• Device Lot Number: 93PB0175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 09/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1