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

Model Number AT75164

Device Problems Material Frayed (1262); Inflation Problem (1310); Peeled/Delaminated (1454); Unraveled Material (1664); Material Deformation (2976)

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

Event Date 02/15/2023

Event Type  malfunction  

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 pta dilatation catheter was returned for evaluation.The returned balloon was noted to be a constrictor and contains unraveled, peeled peebax and frayed fibers, which were noted on the balloon under microscopic observation; 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 6 atm.Upon inflating the balloon, a constriction was noted on the balloon near the distal end, then the balloon was deflated without any issue.No other functional testing was performed.Although during the functional testing the balloon was able to inflate and deflate, a constriction was noted at the distal end upon inflating the balloon, and it was also noted during the visual evaluation; and thus the investigation is confirmed for the reported abnormal inflation.Peeled peebax, unraveled and frayed fibers were able to be observed, hence the investigation is also confirmed for these identified anomalies.A definitive root cause for the reported abnormal inflation issue and identified peeled peebax, unraveled and frayed fibers 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: 09/2025).

Event Description

It was reported that during an angioplasty procedure via upper left vein, the pta balloon allegedly did not inflate completely.It was further reported that the balloon was allegedly constricted in the middle.The procedure was completed using another device.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 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: 16748419
• MDR Text Key: 313402440
• Report Number: 2020394-2023-00257
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062469
• UDI-Public: (01)00801741062469
• 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
• Report Date: 04/11/2023

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: AT75164
• Device Catalogue Number: AT75164
• Device Lot Number: GFGW2385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/15/2023
• 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