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

Model Number	DR8064
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned to bd for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model dr8064 pta balloon dilation catheter experienced a break, peeling, and material rupture.This report was received from one source.This event involved one patient with no patient consequences.The patient was male and patient age and weight were not provided.
Additional Manufacturer Narrative
Of the 1 reported malfunction, the device was returned for evaluation.A lot history review was conducted and it was determined that a device history record (dhr) review was not required.A visual inspection found a partial break in the butt joint between the balloon and catheter shaft.Additionally, peeling pebax was noted on the barrel of the balloon.The investigation is confirmed for a break and for peeling pebax.However, the investigation is inconclusive for the reported balloon rupture as the balloon was unable to be fully inflated due to the break in the butt joint.It is possible that the user perceived the break as a rupture during use.However, the definitive root cause for the reported rupture or the identified joint break and peeling pebax could not be determined based on the available information.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model dr8064 pta balloon dilation catheter experienced a break, peeling, and material rupture.This report was received from one source.This event involved one patient with no patient consequences.The patient was male and patient age and weight were not provided.

• Brand Name: DORADO PTA BALLOON 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: 8500305
• Report Number: 2020394-2019-00264
• Device Sequence Number: 11435218
• 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): 07/23/2019

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: DR8064
• Device Catalogue Number: DR8064
• Device Lot Number: 93UB0116
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1