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

Model Number	ATG120184
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/02/2021
Type of Reportable Event	Serious Injury
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 not 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: 09/2022.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly disconnected from the system.It was further reported that the physician was able to perforate the impacted balloon with a us-guided needle and retrieve the folded balloon in the common femoral vein via open dissection.The current patient status is unknown.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly disconnected from the system.It was further reported that the physician was able to perforate the impacted balloon with a us-guided needle and retrieve the folded balloon in the common femoral vein via open dissection.The current patient status is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned to the manufacturer for evaluation.One document containing three electronic photos of the device was received.First photo shows the device and it is appeared to be bloody.The balloon was noted to be detached from the catheter and the marker bands are noted to be in position.Second photo shows the balloon detached from the catheter and it is noted to be bloody.The marker bands are visible and noted to be in correct position.Third photo also shows the balloon detached from the catheter and it is noted to be bloody.The marker bands are visible and noted to be in correct position.No other anomalies were noted on the device.The reported balloon detachment can be confirmed, since the balloon was noted to be detached from the device in the received electronic photos.The investigation for the reported balloon detachment can be confirmed, since the balloon was noted to be detached from the device in the received electronic photos.A definitive root cause for the reported balloon detachment could not be determined based upon the provided 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: 09/2022), g3, h6 (method).H11: h6 (results and conclusion).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.

• Brand Name: ATLAS GOLD
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12120836
• Report Number: 2020394-2021-01286
• Device Sequence Number: 20037990
• Product Code: DQY
• UDI-Device Identifier: 00801741060885
• UDI-Public: (01)00801741060885
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 07/20/2021

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 Model Number: ATG120184
• Device Catalogue Number: ATG120184
• Device Lot Number: 93VD0093
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 07/22/2021
• 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: Required Intervention
• Patient Age: 43 YR