This report is related to report #9616099-2020-03881.After further review of additional information received the following sections have been updated accordingly: g4, g7, h1, h2, h6, and h11.Complaint conclusion: as reported, the sheath of the three 7f 96cm biopsy forceps long catheter sheath introducer sets clotted off while doing biopsy on the patient.The devices were removed and confirmed that all three devices clotted off.There was no reported patient injury.The devices were used in patient.The devices were stored as per labeling and opened in sterile filed.The product was not returned for analysis.A product history record (phr) review of lot 17938777 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter sheath introducer obstructed - in patient¿ could not be confirmed as the devices were not returned for analysis.The exact cause of the reported events could not be conclusively determined.Patient and procedural factors may have contributed to the reported events.According to the instructions for use (ifu) which is not intended as a mitigation of risk, users are cautioned to inspect for signs of damage prior to and during use.The ifu instructs any product with damage to not be used.Neither the phr review nor the information available for review suggests that the reported events could be related to the manufacturing process of the units.Therefore, no corrective or preventive actions will be taken at this time.
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