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

Model Number	ATG80146
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, lot number was provided, and lot history review being performed.The sample 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 indicates that model atg80146 pta balloon dilatation catheter allegedly experienced retraction problem and detachment of device.The information was received from one source.One patient was involved with no reported patient injury.The male patient is (b)(6) years old and weighs (b)(6) pounds.
Additional Manufacturer Narrative
H10: for the reported event, lot number was provided, and lot history review was performed.The sample was returned for evaluation.Device detachment was confirmed for the device and inconclusive for the reported retraction issue, as device was returned detached and could not be tested for.A root cause has not been determined.The device was 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 malfunction.A review of the reported information indicates that model atg80146 pta balloon dilatation catheter allegedly experienced retraction problem and detachment of device.The information was received from one source.One patient was involved with no reported patient injury.The male patient is 55 years old and weighs 250 pounds.

• Brand Name: ATLAS GOLD 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: 9973397
• Report Number: 2020394-2020-02960
• Device Sequence Number: 16313232
• Product Code: DQY
• UDI-Device Identifier: 00801741060779
• UDI-Public: (01)00801741060779
• 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): 06/26/2020

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: ATG80146
• Device Catalogue Number: ATG80146
• Device Lot Number: 93XD0172
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 06/26/2020
• Patient Sequence Number: 1