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

Model Number ATG80124

Device Problems Entrapment of Device (1212); Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, photos and a video were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 01/2026).

Event Description

It was reported that during an angioplasty procedure, the balloon was allegedly can't exit smoothly using venove post-dilate.There was no reported patient injury.

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 dilatation catheter was returned for evaluation.On the visual evaluation, fiber disturbance and unraveled fibers were noted along with some constrictions; no other specific anomalies were noted.No functional testing was performed due to the condition of the device.Two photos were reviewed.The first photo shows the balloon in a deflated condition; unraveled fibers were able to be observed, and some fiber materials were noted to have wrapped around the balloon material.The second photo was the balloon and device label, on which the product information could be verified.No other anomalies were noted.One radiographic video was reviewed.The video loop demonstrates a balloon that has been inserted to the end of the stented segment being removed.The balloon appears to not be able to move without causing disruption or movement of the iliac vein stent.The balloon appears to be beyond the stented segment.By report, the balloon has been inflated and attempts are being made to remove the balloon.This is causing the stent to move.With large balloons, post inflation the balloons can have significant wings that may be caught on the edge of stents.The curvature of the vein would exacerbate the possibility of getting caught on the stent.Lastly, if the balloon was not completely deflated, this could cause problems with removal.Although the condition of use couldn¿t be replicated under laboratory conditions, the submitted radiographic video confirms the balloon was caught on the edge of the stent and unable to be removed; further, the submitted photo and visual evaluation of the returned sample confirms the unraveled fiber material and fiber disturbance.Hence, the investigation is confirmed for the reported balloon entrapment within the stent and identified unraveled fiber and fiber disturbance respectively.A definitive root cause for the reported balloon entrapment within the stent and identified unraveled fiber and fiber disturbance 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 (expiration date: 01/2026), g3, h6 (device, method) h11: b5, h6 (result, conclusion) h11: section a through f ¿ the information provided 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 : see h10.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly got stuck in the stent at the time of removal.The procedure was completed by changing the guidewire.There was no reported patient injury.

• Brand Name: ATLAS GOLD
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16884885
• MDR Text Key: 314713144
• Report Number: 2020394-2023-00318
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060694
• UDI-Public: (01)00801741060694
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K181323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

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
• Device Operator: Health Professional
• Device Model Number: ATG80124
• Device Catalogue Number: ATG80124
• Device Lot Number: 93NH0121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1