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

Model Number	ATG120244
Medical Device Problem Codes	Retraction Problem (1536); Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
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.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 05/2023).
Event or Problem Description
It was reported that after a procedure, the device was allegedly difficult to be pulled back.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 sample was returned for evaluation and one electronic photo was received.The photo shows the device to be bloody.The photo shows the device to be bloody.The catheter was noted to be bunched and unraveled fibers were noted near its proximal end.No other anomalies were noted.Based on the photo review, identified unraveled fibers can be confirmed, since unraveled fibers were noted.The reported retraction issue and identified detachment cannot be confirmed and remains inconclusive since no such evidence were noted on the submitted photo.One atlas gold pta dilatation catheter returned loaded on a unknown sheath returned for evaluation.The device appeared to be bloody.During visual evaluation, the distal end of the catheter shaft was noted to have several bends, twisted and bunched.The bifurcate was noted to be detached from the device and it was not returned for evaluation.The balloon appeared to be prolapsed, and unraveled fibers were noted near proximal end of the catheter.The distal end of the guidewire was noted to be damaged.No functional testing was done due to the state of the device.All anomalies were magnified under microscope.The investigation for the reported retraction problem can be confirmed, as device was returned loaded on a unknown sheath.The investigation for the identified bifurcate detachment can be confirmed for since it is noted to be detached from the catheter shaft.The investigation for the identified unraveled fibers can be confirmed, as the fibers were noted on the proximal end of the catheter.A definitive root cause for the reported retraction problem, identified unraveled fibers and bifurcate 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: 05/2023), g3, h6 (device).H11: b5, h6 (method, result, conclusion).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.
Event or Problem Description
It was reported that during an angioplasty procedure, the device was allegedly difficult to be pulled back.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: 11290979
• Report Number: 2020394-2021-00149
• Device Sequence Number: 17004223
• Product Code: DQY
• UDI-Device Identifier: 00801741061028
• UDI-Public: (01)00801741061028
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/17/2021

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: ATG120244
• Device Catalogue Number: ATG120244
• Device Lot Number: 93SE0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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