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

Model Number	AT120144
Medical Device Problem Codes	Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2020
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 06/2023).
Event or Problem Description
It was reported that during a angioplasty procedure, the pta balloon allegedly sheared off.There was no reported patient injury.
Event or Problem Description
It was reported that during a angioplasty procedure, the pta balloon allegedly sheared off.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: one atlas gold pta dilation catheter was returned for the evaluation.Visual evaluation was performed and noted that device returned as two segments.Segment one consist of the y-body and the remainder of the catheter with the inner guidewire lumen exposed.There was damage noted to segment one, with fibers unraveled at the proximal joint.Segment two consist of the detached balloon.It was noted there was fiber unraveling and bunching at the proximal end of the balloon.Functional test was not performed due to the condition of the sample.Therefore, the investigation is confirmed for the reported unraveled material issue as fibers unraveled at the proximal joint as well as fiber unraveling at the proximal end of the balloon was noted.The investigation was also confirmed for the identified detachment of the balloon as the device was returned as two segment.A definitive root cause for the unraveled material and detachment of the balloon 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: 06/2023), g3 h11: h6 (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.See h10.

• 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: 10814983
• Report Number: 2020394-2020-20398
• Device Sequence Number: 1127095
• Product Code: DQY
• UDI-Device Identifier: 00801741062636
• UDI-Public: (01)00801741062636
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/25/2021

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: AT120144
• Device Catalogue Number: ATG120144
• Device Lot Number: 93TE0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 05/03/2021
• 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