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

Model Number ATG80144

Device Problems Break (1069); Unraveled Material (1664); Device Dislodged or Dislocated (2923); Material Deformation (2976)

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

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2023).

Event Description

It was reported that during procedure, the distal marker band allegedly came off from the balloon.Patient status was unknown.

Event Description

It was reported that during an angioplasty procedure, the distal marker band allegedly came off from the balloon.Patient status was unknown.

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: two photo was reviewed.Both photos show the balloon appeared bunched and noted to be pulled out the distal end to the proximal end of the catheter, some fiber found unraveled fiber at the proximal end of the balloon.Maker bands are not able to found from the submitted photo, no other specific anomalies noted.Therefore, based on the photo review, the can be confirmed identified unraveled fiber and material deformation, however the reported device dislodged and break could not be confirmed on the findings no conclusion can be made.One atlas gold pta dilatation catheter has returned for evaluation.On the visual evaluation of the device, it appeared bloody and unknown sheath was loaded into the catheter, a circumferential break was noted at the balloon glue joint and unraveled fibers were noted on the device.The balloon appeared bunched and noted to be pulled out the distal end to the proximal end of the catheter.No other specific anomalies noted on the device.On the functional evaluation of the device, an x-ray was performed, and the both the marker bands are present in the balloon, however the proximal marker band is in correct position, but the distal maker band was traveled to the proximal end.Microscopic observation was performed to observe all the anomalies.No further testing performed.Therefore, the investigation was confirmed for the device-dislodge as the x-ray of the balloon confirms the distal marker band has moved from its original position and traveled to the proximal end of the catheter.Both the markers are present in the device.The investigation has confirmed for the identified break as the balloon joint break was noted to the device returned for evaluation.The investigation has confirmed for the material deformation as the balloon appeared to be bunched and the submitted photo also confirms the bunched balloon.The investigation was confirmed for the unraveled fibers as the fiber disturbance noted at the balloon distal end.A definitive root cause for the alleged device dislodge and identified break, unraveled fiber and material deformation could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: b5, d4 (expiry date: 06/2023).H11: section a through f ¿ the information provide 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.

• Brand Name: ATLAS GOLD PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10910792
• MDR Text Key: 218706148
• Report Number: 2020394-2020-20645
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060755
• UDI-Public: (01)00801741060755
• Combination Product (y/n): N
• PMA/PMN Number: K181323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

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: ATG80144
• Device Catalogue Number: ATG80144
• Device Lot Number: 93SE0073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/26/2020
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other