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

Model Number	ATG120144
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photo and video were provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the device allegedly dislocated from its original position.There was no reported patient injury.
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 device was not returned for evaluation.Two photos were reviewed.The first photo shows a atlas gold device labeling.The second photo shows that the catheter appeared bloody and balloon was in deflated position.The break was noted at glue joint of catheter and balloon, no other anomalies were noted.Therefore, based on the photo review, the reported catheter break can be confirmed.One video was reviewed.The video shows that the catheter appeared bloody and balloon was in deflated position and a break was noted at the glue bullet joint of the catheter and no other anomalies were noted.Therefore based on the submitted photo and video the investigation is confirmed for the reported break as the break was noted at the glue bullet of the catheter.A definitive root cause for the catheter break 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.H10: d4 (expiry date: 04/2023).H11: 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.H3 other text : device not returned.
Event or Problem Description
It was reported that during an angioplasty procedure, the device allegedly dislocated from its original position.There was no reported patient injury.

• 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: 11480495
• Report Number: 2020394-2021-00544
• Device Sequence Number: 17095004
• Product Code: DQY
• UDI-Device Identifier: 00801741060762
• UDI-Public: (01)00801741060762
• 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): 04/28/2021

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: ATG120144
• Device Catalogue Number: ATG120144
• Device Lot Number: 93QE0089
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 05/28/2021
• 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: Other