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

Model Number	ATG80146
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2024).
Event or Problem Description
It was reported that during the procedure, the pta balloon allegedly detached from the shaft.There was no reported patient injury.
Event or Problem Description
It was reported that after the procedure, the pta balloon allegedly got detached from the shaft.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: a sample evaluation was not performed as the device was not returned, but 1 electronic photo was provided for review.The photo shows an atlas gold and a dorado device.The balloon and a portion of the inner lumen are noted to be detached from the rest of the catheter shaft.The balloon refold tool is over the middle segment of the balloon.Therefore, based on the photo review, the detachment can be confirmed.Per the reported event details, the user performed testing on the device post procedure that led to the detachment.The detachment did not occur during use of the device.It is unknown the exact testing the user performed on the device.Therefore, the cause of the detachment is likely due to the testing performed by the user.A definitive root cause of the detachment could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 02/2024).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.H3 other text : device not returned.

• 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: 12363944
• Report Number: 2020394-2021-01500
• Device Sequence Number: 19916892
• Product Code: DQY
• UDI-Device Identifier: 00801741060779
• UDI-Public: (01)00801741060779
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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: Health Professional
• Device Model Number: ATG80146
• Device Catalogue Number: ATG80146
• Device Lot Number: 93PF0003
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/10/2021
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1