Catalog Number 9-ACP2-007-016 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that on 01 november 2023, a 20mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 12f amplatzer amulet delivery sheath.The sizing was determined by fluoroscopy and transoesophageal echocardiogram (toe).During procedure, the activated clotting time (act) was 320 seconds.The 20mm device was advanced through delivery sheath and placed.It was noted that device was grossly oversized, and the decision was made to downsize.The 20mm device was removed from the patient prior to release from the delivery cable.The physician decided to not to change the sheath, and a new 18mm amplatzer amulet left atrial appendage occluder was chosen for implant.The 18mm amulet was prepared and delivered into the same delivery sheath and placed into appendage.On echocardiogram, a fiber was floating in left atrium.The 18mm device removed from the patient prior to release from the delivery cable.The device was withdrawn, and the long fiber was clearly able to be seen.A new 16mm amplatzer amulet left atrial appendage occluder was then prepared and placed using the same delivery system.It was noted that another fiber was floating in left atrium, and it was 2.1cm long.The device was implanted.The fiber was still seen on toe at the end of the procedure.The patient remained hemodynamically stable throughout the procedure.No further action was taken.
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Manufacturer Narrative
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An event of foreign material (fiber) was reported.A returned device inspection, to rule out any device-related causes, 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, including inspections of foreign materials.A photo was received from the account which appeared to show a fiber like on the device; however; a device inspection could not be performed as the device was not returned for analysis.Based on the information received, a cause for the reported of fiber on the device 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 respect to labeling design or manufacturing of the device.
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Event Description
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Related manufacturer report number: 2135147-2023-05153.It was reported that on (b)(6) 2023, a 20mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 12f amplatzer amulet delivery sheath.The sizing was determined by fluoroscopy and transoesophageal echocardiogram (toe).During procedure, the activated clotting time (act) was 320 seconds.The 20mm device was advanced through delivery sheath and placed.It was noted that device was grossly oversized, and the decision was made to downsize.The 20mm device was removed from the patient prior to release from the delivery cable.The physician decided to not to change the sheath, and a new 18mm amplatzer amulet left atrial appendage occluder was chosen for implant.The 18mm amulet was prepared and delivered into the same delivery sheath and placed into appendage.On echocardiogram, a fiber was floating in left atrium.The 18mm device removed from the patient prior to release from the delivery cable.The device was withdrawn, and the long fiber was clearly able to be seen.A new 16mm amplatzer amulet left atrial appendage occluder was then prepared and placed using the same delivery system.It was noted that another fiber was floating in left atrium, and it was 2.1cm long.The device was implanted.The fiber was still seen on toe at the end of the procedure.The patient remained hemodynamically stable throughout the procedure.No further action was taken.
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Search Alerts/Recalls
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