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

Model Number	DR80510
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The company is still investigating the issue at this time.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 dr80510 pta balloon dilatation catheter allegedly peeled.Another balloon was used to complete the procedure.There was no reported patient involvement.This information was received from one source.The patient was a (b)(6) male who weighed (b)(6).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model: dr80510 pta balloon dilatation catheter allegedly peeled.Another balloon was used to complete the procedure.This information was received from one source.This malfunction did not involve a patient with no patient consequences.The patient was a 71-year-old male who weighed 66 kilograms.
Additional Manufacturer Narrative
H10: the device was returned to bd for evaluation.The investigation identified balloon kink.Based on the information provided, the definitive root cause is unknown.The device is labeled for single use. h11: b5: event, h6 (device, results, conclusion).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.
Additional Manufacturer Narrative
H10: one device was returned to bd for evaluation for the reported malfunction.The lot number was provided and a lot history review was performed.Seven electronic photos were provided for review.The investigation identified material deformation.Based on the information provided, the definitive root cause is unknown.The device is labeled for single use.  h10: g4 h11: b5, g1 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 dr80510 pta balloon dilatation catheter allegedly experienced material deformation and peeled/delaminated.This information was received from one source.This malfunction did not involve a patient.The patient was a 71-year-old male who weighed 66 kilograms.

• 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: 8812449
• Report Number: 2020394-2019-01666
• Device Sequence Number: 2576131
• Product Code: DQY
• UDI-Device Identifier: 00801741058578
• UDI-Public: (01)00801741058578
• 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,Followup
• Report Date (Section B): 01/20/2020

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: DR80510
• Device Catalogue Number: DR80510
• Device Lot Number: 93YB0069
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019; 12/31/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/14/2019; 01/20/2020
• Patient Sequence Number: 1