BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Perforation (2513); Pericardial Effusion (3271)
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Event Date 08/04/2023 |
Event Type
Injury
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Manufacturer Narrative
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It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
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Event Description
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It was reported that a cardiac perforation and pericardial effusion occurred.A versacross connect was selected for use along with watchman devices.The transseptal puncture was performed in low-mid on the transseptal, with no difficulties or complications noted, even thought, no adequate image with transesophageal echocardiogram (tee) was available at the time.The appendage was accessed, and no issues were reported with the versacross devices.Only one radio frequency was applied, and the versacross rf wire was tenting as normal (1-3mm).Once the versacross dilator was in the superior vena cava along with watchman sheath, a deployment of a 31mm wds with a double curve was sheath was attempted but was unsuccessful.The physician then changed to single curve was sheath and a 27mm wds.During the deployment of the 27mm closure device, it was noted that there was a small perforation of the left atrial appendage (small and localized) and a pericardial effusion noted on the left atrium appendage.The perforation was noted sometime in between deployment of watchman devices.The patient's vitals were assessed, and the patient remained stable.There was no intervention required for the perforation, and the physician decided to abort the procedure.There were no further complications reported and the patient was fully recovered and discharged.The device is not expected to be returned for analysis (it was disposed).The cause of the perforation was determined unclear.Act therapeutic was used during the procedure.
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Manufacturer Narrative
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The field b5 (describe event or problem) was updated.Thus, a supplemental medwatch is being filed.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
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Event Description
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It was reported that a cardiac perforation and pericardial effusion occurred.A versacross connect was selected for use along with watchman devices.The transseptal puncture was performed in low-mid on the transseptal, with no difficulties or complications noted, even thought, no adequate image with transesophageal echocardiogram (tee) was available at the time.The appendage was accessed, and no issues were reported with the versacross devices.Only one radio frequency was applied, and the versacross rf wire was tenting as normal (1-3mm).A deployment of a 31mm wds with a double curve was sheath was attempted but was unsuccessful.The physician then changed to single curve was sheath and a 27mm wds.During the deployment of the 27mm closure device, it was noted that there was a small perforation of the left atrial appendage (small and localized) and a pericardial effusion noted on the left atrium appendage.The perforation was noted sometime in between deployment of watchman devices.The patient's vitals were assessed, and the patient remained stable.There was no intervention required for the perforation, and the physician decided to abort the procedure.There were no further complications reported and the patient was fully recovered and discharged.The device is not expected to be returned for analysis (it was disposed).The cause of the perforation was determined unclear.Act therapeutic was used during the procedure.Due to a correction on 12ct2023, the statement "once the versacross dilator was in the superior vena cava along with watchman sheath, a deployment of a 31mm wds with a double curve was sheath was attempted but was unsuccessful." was replaced by "a deployment of a 31mm wds with a double curve was sheath was attempted but was unsuccessful.".
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