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

Model Number AT75144

Device Problems Material Frayed (1262); Inflation Problem (1310); Material Rupture (1546); Unraveled Material (1664); Material Deformation (2976)

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

Event Date 01/17/2023

Event Type  malfunction  

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, photos and images were provided for review.The investigation of the reported event is currently underway.Expiry date: 08/2025.

Event Description

It was reported that during an angioplasty in the left radiocephalic, the balloon allegedly failed to inflate.It was further reported that balloon fibers allegedly frayed and unraveled from inside the balloon.The procedure was completed using another balloon.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 returned for evaluation.Unraveled and frayed fibres were noted on the balloon; no other specific anomalies were noted during the visual evaluation.During the functional testing, the balloon was inflated with the in-house presto inflation device up to 4 atm, and water was noted to be leaking from the balloon near the distal end.Upon inflating the balloon, a constriction was noted on the balloon near to distal end, then the balloon fibres were removed, and a pin-hole rupture was noted at the distal tip of the balloon under microscopic observation.No other functional testing was performed.Three photos were reviewed.All three photos show the balloon was in a deflated condition, and the fibers were noted to have unraveled and frayed near the distal end of the balloon.No other anomalies were noted.Two images were reviewed.Two limited fluoroscopic images are reviewed.They both show a partially inflated angioplasty balloon.It is difficult to determine the exact location of this because of the poor quality of the provided image.There is no evidence of balloon leakage.The provided media is not helpful in confirming this event.A fluoroscopic video would be more instructive, if available.Based on the submitted photo review and visual evaluation of the returned sample, unraveled and frayed fibres were able to be observed, hence the investigation was confirmed for these reported anomalies.The investigation was also confirmed to have identified pin-hole balloon rupture as during the microscopic observation these anomalies were noted and during the functional testing upon inflation the balloon was also noted to be leaking.A definitive root cause for the reported abnormal inflation, unraveled and frayed fibers and identified pin-hole balloon rupture 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: 08/2025).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 in the left radiocephalic vein, the distal tip of the balloon was not completely effaced not on the stenosis.However, the balloon was moved more proximal and tried to inflate again and still noticed that the distal tip of the balloon was not completely effaced.It was further reported that the physician attempted to plasty again on the stenosis and noticed the pressure drop on the inflator.Reportedly the balloon was pulled out from the patient and was noticed the nylon fibers seem to have been frayed from inside the balloon.The procedure was completed using another balloon.There was no reported patient injury.

• 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: 16359852
• MDR Text Key: 309498823
• Report Number: 2020394-2023-00061
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062438
• UDI-Public: (01)00801741062438
• 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
• Report Date: 03/06/2023

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: AT75144
• Device Catalogue Number: AT75144
• Device Lot Number: GFGU3152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/12/2023
• Supplement Dates Manufacturer Received: 03/10/2023
• Supplement Dates FDA Received: 03/26/2023
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic