MAUDE Adverse Event Report: CORDIS CORPORATION CSI LONG 7F 96CM MP; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17938777 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
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 devices are expected to be returned for evaluation.
Additional Manufacturer Narrative
This report is related to report #9616099-2020-03882 and report #9616099-2020-03883.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.

• Brand Name: CSI LONG 7F 96CM MP
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10489924
• Report Number: 9616099-2020-03881
• Device Sequence Number: 4093411
• Product Code: DYB
• UDI-Device Identifier: 20705032009536
• UDI-Public: 20705032009536
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K945524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 501613A
• Device Lot Number: 17938777
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1