Lot Number 0031079376 |
Device Problems
Difficult to Flush (1251); Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/25/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
|
|
Event Description
|
It was reported that during a cryo ablation procedure using a polarsheath the luer on the side port detached.They exchanged the sheath, and the issue was resolved.The procedure was then completed with no patient complications.The sheath is expected to be returned for analysis.
|
|
Event Description
|
It was reported that during a cryo ablation procedure using a polarsheath the luer on the side port detached.They exchanged the sheath, and the issue was resolved.The procedure was then completed with no patient complications.The sheath has been received by boston scientific for analysis.
|
|
Manufacturer Narrative
|
Upon receipt at boston scientific's post market laboratory the sheath was visually inspected which revealed that the irrigation luer was completely separated from the flush lumen.This irrigation luer had not been returned with the rest of the sheath.Adhesive was found on the flush lumen; however, it was noted that the trace adhesive present would be inadequate in adhering the luer to the flush lumen tubing.The reported allegation of irrigation failure was confirmed, and the root cause for the occlusion was traced to manufacturing deficiency due to the inadequate adhesive amount.Separated tubing would prevent irrigation fluid from entering the sheath and proper irrigation would be unable to occur.
|
|
Search Alerts/Recalls
|