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

Catalog Number	ATG80186
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	08/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during an angioplasty of an in stent re-stenosis in the iliac vein, the pta balloon allegedly detached from the catheter shaft during an inflation attempt.Reportedly, the heath care provider (hcp) attempted to retrieve the detached segment using a snare device but was unsuccessful.The hcp decided to send the patient to a local hospital e.R.For removal of the detached balloon segment.The patient was reported as asymptomatic.
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that during an angioplasty of an in stent re-stenosis in the iliac vein, the pta balloon allegedly detached from the catheter shaft during an inflation attempt.Reportedly, the heath care provider (hcp) attempted to retrieve the detached segment using a snare device but was unsuccessful.The hcp decided to send the patient to a local hospital e.R.For removal of the detached balloon segment.The patient was reported as asymptomatic.

• 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: 7895167
• Report Number: 2020394-2018-01748
• Device Sequence Number: 11111365
• Product Code: LIT
• UDI-Device Identifier: 00801741060892
• UDI-Public: (01)00801741060892
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ATG80186
• Device Lot Number: 93TC0139
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention