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

Model Number	ATG120166
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
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: the physical device was not returned for evaluation.Three photos was reviewed.All the three photos shows the catheter loaded into a unknown introducer sheath and noted to be bloody.The balloon noted to be stuck within the sheath and the distal end of the balloon noted to be bunched and prolapsed, no other specific damage noted on the photos.Therefore, based on the photo review, the reported difficult to remove can be confirmed as the catheter noted to be stuck within the sheath.Therefore the investigation was confirmed for the reported the reported difficult to remove as the catheter noted to be stuck within the sheath was observed from the submitted photo.A definitive root cause for the difficult to remove 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.(expiry date: 03/2022).
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly got stuck in the sheath during removal.The procedure was completed using another sheath.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: 12603121
• Report Number: 2020394-2021-01847
• Device Sequence Number: 1428640
• Product Code: DQY
• UDI-Device Identifier: 00801741060847
• UDI-Public: (01)00801741060847
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 09/24/2021

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: ATG120166
• Device Catalogue Number: ATG120166
• Device Lot Number: 93QD0046
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR