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

Catalog Number	DR8074
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The lot met all release criteria.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.A complete circumferential shaft break was noted at the proximal butt joint.However the polyimide appeared to be intact.The edges of the break were examined under microscopic magnification and the edges of the break were slightly jagged.The catheter was kinked throughout it's length.However as the user did not report any kinks, it is likely that the manner in which the device was packaged for return may have contributed to the kinks.No other anomalies were observed to the device at this time.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house.035" guidewire, and it was unable to pass at the location of the kinks.No further functional testing could be performed due to the break at the proximal balloon glue joint.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 investigation is confirmed for a complete circumferential break at the butt joint.The root cause for the complete break at the proximal balloon butt 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 instructions for use (ifu) states: warnings: when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated.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.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 precautions: if resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon.If resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit.Use of the dorado pta dilatation catheter: while maintaining negative pressure and the position of the guidewire, grasp the balloon catheter just outside the sheath and withdraw the deflated dilatation catheter over the wire through the introducer sheath.Use of a gentle clockwise motion may be used to help facilitate catheter removal through the introducer sheath.(b)(4).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 in the cephalic vein, a break was allegedly identified on the catheter shaft of the pta balloon device on the last inflation.There was no reported retraction issues.The procedure was concluded, and no further treatment was provided.There was no reported patient injury.

• Brand Name: DORADO PTA BALLOON 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: 6091605
• Report Number: 2020394-2016-01050
• Device Sequence Number: 10904767
• Product Code: DQY
• UDI-Device Identifier: 00801741058981
• UDI-Public: (01)00801741058981(17)180531(10)93EZ0024
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2016

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: 05/31/2018
• Device Catalogue Number: DR8074
• Device Lot Number: 93EZ0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2016
• Initial Report FDA Received Date: 11/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 103