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

Model Number	DR8064
Medical Device Problem Codes	Material Puncture/Hole (1504); Retraction Problem (1536); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.(b)(4).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model dr8064 pta balloon dilatation catheter allegedly experienced material puncture/ hole, detachment of device or device component, retraction problem and break.This information was received from one source.This malfunction involved one patient with no consequences.The weight of (b)(6) male is (b)(6).
Additional Manufacturer Narrative
H10: the lot number was provided; therefore, a lot history review was performed.The sample was returned, and the investigation confirmed for device detachment and balloon material deformation.The investigation is inconclusive for the reported balloon puncture.A definite root cause for the reported event could not be determined.The device was labeled for single use.H10: g4, h6 (device code + description3).H11: g1, h6 (results 1, conclusion 1).H11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model dr8064 pta balloon dilatation catheter allegedly experienced material puncture/ hole, detachment of device or device component, retraction problem and break.This information was received from one source.This malfunction involved one patient with no consequences.The weight of 72 year old male is 140 pounds.

• Brand Name: DORADO PTA 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: 9974072
• Report Number: 2020394-2020-02982
• Device Sequence Number: 678942
• Product Code: DQY
• UDI-Device Identifier: 00801741058721
• UDI-Public: (01)00801741058721
• 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): 07/08/2020

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: DR8064
• Device Catalogue Number: DR8064
• Device Lot Number: 93TD0134
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 07/08/2020
• Patient Sequence Number: 1