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

Model Number	ATG120164
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2021
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 return of the sample is pending.The investigation of the reported event is currently underway.Expiry date: 05/2024.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly ruptured.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 dilatation catheter has been received for the evaluation.On the visual evaluation, the device was noted to be clean and the balloon was noted to be detached from the catheter.On further the fibers were noted on the distal end of the catheter.Bunching, stretching and kinks were observed to the inner guide-wire lumen.The glue bullet was noted not to be seated in the correct position.All marker bands were present however the marker bands were noted to be dislocated on the inner guide-wire lumen and no other anomalies were noted.No other functional testing performed due to the condition of the returned device.The investigation for the identified detachment of balloon was confirmed, as the balloon got detached and not returned for the evaluation.The investigation for the identified marker bands dislodgement was also confirmed as the balloon was noted to be dislodged on the device returned for the evaluation.Therefore the investigation for the reported balloon rupture remains inconclusive, due to the condition of the returned device.The investigation for the reported difficult to remove remains inconclusive, due to the condition of the returned device.A definitive root cause for the reported balloon rupture, difficult to remove and the identified detachment of balloon, marker bands dislodgement 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: b5, d4 (expiry date: 05/2024), g3, h6 (device).H11: h6 (method, result, conclusion).H11:section a through f - the information provided by bd represents all of 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 : see h10.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at nominal pressure.It was further reported that the balloon was allegedly difficult to remove.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: 12531311
• Report Number: 2020394-2021-01803
• Device Sequence Number: 13822899
• Product Code: DQY
• UDI-Device Identifier: 00801741060823
• UDI-Public: (01)00801741060823
• 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,Followup
• Report Date (Section B): 10/06/2021

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: ATG120164
• Device Catalogue Number: ATG120164
• Device Lot Number: 93SF0041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR