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

Catalog Number	DR13554
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device, no medical records, or no medical images were provided to the manufacturer.The lot number for the device was not provided; therefore, a review of the device history records could not be performed.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 procedure, the marker bands of the pta balloon catheter allegedly appeared too close to each other.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation was inconclusive, as the sample was not returned for evaluation.The definitive root cause could not be determined based upon the available information.It was unknown if patient and/or procedural issues contributed to the dislodgement of the distal marker band.Labeling review: the current ifu (instructions for use) states: precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.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.Use: apply negative pressure to fully evacuate fluid from the balloon.Confirm that the balloon is fully deflated under fluoroscopy and that no contrast is left in the balloon.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 procedure, the marker bands of the pta balloon catheter allegedly appeared too close to each other.There was no reported patient injury.
Additional Manufacturer Narrative
The previously submitted supplemental emdr inaccurately reported the date received by manufacturer date of 01/04/2016.The date received by manufacturer date on the supplemental should have been reported as 01/04/2017.Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation was inconclusive, as the sample was not returned for evaluation.The definitive root cause could not be determined based upon the available information.It was unknown if patient and/or procedural issues contributed to the dislodgement of the distal marker band.Labeling review: the current ifu (instructions for use) states: precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.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.Use: apply negative pressure to fully evacuate fluid from the balloon.Confirm that the balloon is fully deflated under fluoroscopy and that no contrast is left in the balloon.
Event or Problem Description
It was reported that during the procedure, the marker bands of the pta balloon catheter allegedly appeared too close to each other.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: 6129731
• Report Number: 2020394-2016-01111
• Device Sequence Number: 13505871
• Product Code: DQY
• UDI-Device Identifier: 00801741058516
• UDI-Public: (01)00801741058516
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2018

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 Catalogue Number: DR13554
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2016
• Supplement Date Received by Manufacturer: Not provided; 06/14/2018
• Initial Report FDA Received Date: 11/28/2016
• Supplement Report FDA Received Date: 01/05/2017; 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1