Catalog Number 9-ASD-024 |
Device Problem
Difficult to Fold, Unfold or Collapse (1254)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/16/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Event Description
|
It was reported that a 24mm amplatzer septal occluder was selected for implant on (b)(6)2023.During implant, the device took on a cobra shape.The device was removed from the patient and placed in warm saline for five minutes.The device was noted to return to its original shape.Another attempt to implant the device was made.The device took on a cobra shape again.The device was removed from the patient.The device interacted with the left and right atriums.There were no angulations or kinks noted in the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedure.There were no adverse effects to the patient.
|
|
Manufacturer Narrative
|
An event of device deployed into a cobra shape was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Per the instructions for use, the recommended size delivery system for use with a 24 mm amplatzer septal occluder is an 9f.A 10f sheath was used to deliver the device, which could have contributed to the deformed deployment noted, as use of a larger sheath may influence deformations of the device.Based on the information received, the cause of the reported event could not be conclusively determined.
|
|
Manufacturer Narrative
|
An event of device deformity was reported.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.Information from field indicated that there were no interactions with cardiac structures and no angulation/kink observed with the delivery system.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Per the instructions for use, the recommended size delivery system for use with a 24 mm amplatzer septal occluder is an 9f.A 10f sheath was used to deliver the device, which could have contributed to the deformed deployment noted, as use of a larger sheath may influence deformations of the device.The cause of reported event could not be conclusively determined.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
|
|
Search Alerts/Recalls
|