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

Model Number	ATG80186
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 07/2023).
Event or Problem Description
It was reported that during a procedure through the brachiocephalic vein, the device allegedly ruptured.The doctor deflated the balloon and noticed blood on the device.Upon inspection, the balloon was found to be badly damaged.The current status of the patient is unknown.
Additional Manufacturer Narrative
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: one atlas gold pta dilatation catheter loaded onto an unknown sheath was received.Balloon appeared to be bloody, prolapsed/inverted and stretching.The glue bullet was noticed to be pulled back exposing the inner gw which had multiple kinks.Break was found between proximal end of balloon and weld joint and still attached.Both the marker bands are present in the correct position.No other anomalies noted on the device returned for evaluation.All the anomalies were observed under microscope for evaluation.No functional evaluation performed due to the condition of the device which returned for evaluation.The investigation for the reported break, identified material deformation and difficult to remove can be confirmed, as the break is noticed in glue bullet pulled back from the proximal weld joint exposing the inner guide wire which had multiple kinks.However, the investigation remains inconclusive for the reported balloon rupture as no evidence was observed on the device and no functional evaluation performed due to the condition of the device which returned for evaluation.A definitive root cause for the balloon rupture, break ,material deformation and difficult to remove could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.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
It was reported that during a procedure through the brachiocephalic vein, the device allegedly ruptured.The hcp used a needle stick to deflate the balloon.It was further reported that blood was identified in the inflation device.Reportedly, the balloon was found damaged.The current status of the patient is unknown.

• 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: 11449842
• Report Number: 2020394-2021-00496
• Device Sequence Number: 4049011
• Product Code: DQY
• UDI-Device Identifier: 00801741060892
• UDI-Public: (01)00801741060892
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 04/02/2021

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: ATG80186
• Device Catalogue Number: ATG80186
• Device Lot Number: 93TE0067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 03/10/2021
• 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