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

Model Number	DR8084
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The company is still investigating the issue currently.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model dr8084 pta balloon dilatation catheter allegedly became stuck, and the distal tip detached inside the introducer sheath.The balloon and sheath were removed as a single unit.No further devices were needed to finish the procedure.There was no reported patient injury.This information was received from one source.The patient was a (b)(6) year old female who weighed (b)(6).
Additional Manufacturer Narrative
H10: the device was returned to bd for evaluation.The investigation is confirmed for shaft detachment as the catheter was detached distally from the glue butt joint.The investigation is inconclusive for a retraction issue as the sheath was cut before being returned.Based on the information available, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model dr8084 pta balloon dilatation catheter allegedly became stuck, and the distal tip detached inside the introducer sheath.The balloon and sheath were removed as a single unit.No further devices were needed to finish the procedure.This information was received from one source.This malfunction did involve a patient and there was no reported patient injury.The patient was a 29-year-old female who weighed 119 pounds.

• Brand Name: DORADO PTA DILATATON 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: 8824315
• Report Number: 2020394-2019-01843
• Device Sequence Number: 2348717
• Product Code: DQY
• UDI-Device Identifier: 00801741059254
• UDI-Public: (01)00801741059254
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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: No Information
• Device Model Number: DR8084
• Device Catalogue Number: DR8084
• Device Lot Number: 93ND0149
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 10/14/2019
• Patient Sequence Number: 1