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

Catalog Number	DR8044
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2017
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 device was 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 during the first inflation, the pta balloon catheter allegedly would not hold pressure beyond 24 atm.The balloon catheter was exchanged over the guidewire for another and the procedure was completed.Upon removal of the balloon catheter, the health care provider allegedly identified a break at the balloon-catheter butt joint.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.Visual inspection: the device was returned without product labeling or packaging.The balloon size for this product is printed on the hub and identified the returned sample as a 4mm x 4cm balloon.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 able to pass without issue.The inflation hub was connected to an inflation device and water was used to inflate the balloon.The balloon was inflated to nominal and rated burst pressure (rbp) without issue.Once rbp was reached, the balloon was inspected and no leaks or breaks in the device were noted.The balloon was deflated without issue.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the device was returned.A visual inspection did not find any breaks or break related failures on the device.Additionally, an in-house guidewire was inserted without issue and the balloon was inflated and deflated without issue.The investigation was unconfirmed for the reported break.The definitive root cause for the reported break could not be determined based upon the available information.It was unknown if procedural issues contributed to the reported 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 during the first inflation, the pta balloon catheter allegedly would not hold pressure beyond 24 atm.The balloon catheter was exchanged over the guidewire for another and the procedure was completed.Upon removal of the balloon catheter, the health care provider allegedly identified a break at the balloon-catheter butt joint.There was no reported patient injury.

• Brand Name: DORADO PTA BALLOON CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6655754
• Report Number: 2020394-2017-00678
• Device Sequence Number: 11084058
• Product Code: DQY
• UDI-Device Identifier: 00801741058301
• UDI-Public: (01)00801741058301(17)200320(10)93QB0099
• 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,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2017

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: 03/20/2020
• Device Catalogue Number: DR8044
• Device Lot Number: 93QB0099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 08/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1