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

Model Number	DR8088
Medical Device Problem Codes	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided; therefore, a lot history review is currently being performed.The device was returned to the manufacturer 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 dr8088 pta balloon dilatation catheter allegedly experienced retraction problems and break.This information was received from one source.One patient was involved with no patient consequences.The patient was a (b)(6) year old male.Weight information was not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model dr8088 pta balloon dilatation catheter allegedly experienced retraction problems and break.This information was received from one source.One patient was involved with no patient consequences.The patient was a 78 year old male.Weight information was not provided.
Additional Manufacturer Narrative
H10: the lot number for the device was provided and a lot history review was conducted and it was determined that a device history record (dhr) review was not required.The device was returned to the manufacturer for evaluation and the investigation was confirmed for the reported retraction issue and joint break.The retraction issue may have contributed to the balloon joint break.However, the definitive root cause could not be determined based on the available information.The device is labeled for single use.

• 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: 9965272
• Report Number: 2020394-2020-02780
• Device Sequence Number: 19520397
• Product Code: DQY
• UDI-Device Identifier: 00801741059322
• UDI-Public: (01)00801741059322
• 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): 07/02/2020

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: DR8088
• Device Catalogue Number: DR8088
• Device Lot Number: 93WD0072
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 07/02/2020
• Patient Sequence Number: 1