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

Model Number	DR8084
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review will be performed.The device has been returned for evaluation; the evaluation identified material deformation and a break.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported information indicated that model dr8084 pta balloon dilatation catheter allegedly experienced a break and material deformation.This information was received from one source.The malfunction did not involve a patient as there was no patient contact.The (b)(6) year old male patient's weight was not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review will be performed.The device has been returned for evaluation; the evaluation confirmed for break, however, unconfirmed for material deformation.The evaluation was reassessed and the trending device code (2976 - material deformation ) has been removed.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.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 (1) malfunction.A review of the reported information indicated that model dr8084 pta balloon dilatation catheter allegedly experienced a break and material deformation.This information was received from one source.The malfunction did not involve a patient as there was no patient contact.The 74 year old male patient's weight was not provided.

• 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: 8824241
• Report Number: 2020394-2019-01835
• Device Sequence Number: 3027107
• 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): 04/07/2020

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: DR8084
• Device Catalogue Number: DR8084
• Device Lot Number: 93PC0024
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 04/08/2020
• Patient Sequence Number: 1