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

Model Number	ATG120144
Medical Device Problem Codes	Deflation Problem (1149); Material Rupture (1546); Unraveled Material (1664); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/21/2020
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 return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 11/2022).
Event or Problem Description
It was reported that during a procedure, the balloon was allegedly unable to deflate.It was further reported that the balloon ruptured and the shaft was removed.The patient had to undergo stenting to make sure the balloon pieces did not travel throughout the body.The current status of the patient is unknown.
Event or Problem Description
It was reported that during a procedure, the balloon was allegedly unable to deflate.It was further reported that the balloon ruptured and the shaft was removed.The patient had to undergo stenting to make sure the balloon pieces did not travel throughout the body.The current status of the patient is unknown.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one atlas gold pta catheter was returned for evaluation.A visual inspection was performed and the sample was bloody.One kink was noted to the catheter.The balloon was detached and not returned.Unraveling noted at the proximal balloon joint and the glue bullet was pulled.During functional testing the inflation lumen was inflated.The glue pullet was maneuvered and water was able to exit out of the port holes.Therefore the investigation is confirmed for the reported detachment issue as balloon was detached and not present in the device.The investigation is also confirmed for the identified kink and unraveled material issue as kink and unraveling noted.The investigation is inconclusive for the reported material rupture and deflation issue as balloon was not returned for evaluation.A definitive root cause for the reported and identified failures 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.Section a through f ¿ the information provide by bd represents all 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 PTA DILATION 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: 11184259
• Report Number: 2020394-2020-21069
• Device Sequence Number: 3649161
• Product Code: DQY
• UDI-Device Identifier: 00801741060762
• UDI-Public: (01)00801741060762
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

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: ATG120144
• Device Catalogue Number: ATG120144
• Device Lot Number: 93YD0093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 05/24/2021
• 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: 71 YR
• Patient Weight: 80