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

Model Number	ATG80166
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the one malfunction, as the lot number for the device was not provided, a lot history review could not be performed.The sample was returned to the manufacturer for inspection/evaluation.The company is still investigating the issue at this time.Device (unraveled material - 1664).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model atg80186 pta balloon dilatation catheter allegedly experienced balloon detachment, retraction issue, marker bands not in location and unraveling fibers.This information was received from one source.This malfunction involved one patient with no consequences.The patient is a (b)(6) year old male weighs (b)(6) lbs.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, therefore, a lot history review could not be performed.The device was returned to the manufacturer for evaluation.Therefore, the investigation is confirmed for device detachment and dislodged marker bands; however, the investigation is inconclusive for retraction issue and balloon rupture.A definitive root cause could not be determined.The device is labeled for single use.H10: g4, h6 (device: 1546).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 atg80186 pta balloon dilatation catheter allegedly experienced balloon detachment, retraction issue, marker bands not in location and material rupture.This information was received from one source.This malfunction involved one patient with no consequences.The patient is a 53 year old male weighs 210 lbs.

• 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: 10737027
• Report Number: 2020394-2020-06085
• Device Sequence Number: 19361268
• Product Code: DQY
• UDI-Device Identifier: 00801741060830
• UDI-Public: (01)00801741060830
• 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): 01/06/2021

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: ATG80166
• Device Catalogue Number: ATG80186
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 01/06/2021
• Patient Sequence Number: 1