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

Catalog Number AT75144

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

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

Event Date 06/09/2023

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure, the string from the pta balloon allegedly snagged on a stent.There was no reported patient injury.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, photo was provided for review.The investigation of the reported event is currently underway.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 : device not returned.

Event Description

It was reported that during an angioplasty procedure in common to external iliac vein via the front femoral access, resistance was felt during an attempt to remove the balloon catheter.It was further reported that upon contrast it was found that the balloon material was allegedly unraveled and was stuck with the stent.Reportedly, the health care provider resolved by partially re-inflated the balloon within the stent, freed the balloon material from the stent, and removed the balloon catheter without further issue.The procedure was completed using same device.There was no reported patient injury.

Manufacturer Narrative

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, a photo was provided for review.The investigation of the reported event is currently underway.D4 (expiry date: 04/2026).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.

Event Description

It was reported that during an angioplasty procedure in common to external iliac vein via the front femoral access, resistance was felt during an attempt to remove the balloon catheter.It was further reported that upon contrast it was found that the balloon material was allegedly unraveled and was stuck with the stent.Reportedly, the healthcare provider resolved by partially re-inflated the balloon within the stent, freed the balloon material from the stent, and removed the balloon catheter without further issue.The procedure was completed using same device.There was no reported patient injury.

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: one atlas pta dilatation catheter was received for evaluation.During visual evaluation, unraveling of the balloon fibers could be seen.No anomalies noted to the luers/bifurcate.No functional testing was performed due to the nature of the complaint.One photo was provided and reviewed.The photo shows the atlas balloon deflated and bloody.Unraveling of the balloon fibers can be seen.No other anomalies noted.Therefore, the investigation is confirmed for the reported unraveled material as unraveling of the balloon fibers could be seen.However, the investigation is inconclusive for the reported entrapment of device as the conditions of use could not be replicated in the laboratory.A definitive root cause for the alleged entrapment of device and unraveled material 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.D4 (expiry date: 04/2026).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.

• Brand Name: ATLAS
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17286047
• MDR Text Key: 318649059
• Report Number: 2020394-2023-00506
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2023

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 Catalogue Number: AT75144
• Device Lot Number: GFHR0586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 07/20/2023; 09/20/2023
• Supplement Dates FDA Received: 08/16/2023; 09/24/2023
• 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