MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	G28445
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an ivc filter retrieval procedure, a performer introducer sheath broke while trying to remove the filter.The retrieval was noted the be difficult.Additional patient and event information has been requested.
Additional Manufacturer Narrative
Initial reporter occupation: occupation: operations coordinator.Pma/510k #: k171999.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
Additional information received on 14feb2022: access was gained via the right internal jugular vein and advanced to the inferior vena cava.The anatomy was not noted to be tortuous or calcified.The user did note that there was resistance at some point during the procedure.The tip of the sheath split when pulling the filter into the sheath.No portion of the device was left within the patient.There was no need for additional procedures or prolonged hospitalization.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a difficult ivc filter retrieval procedure, a performer introducer sheath broke while trying to remove the filter.Access was gained via the right internal jugular vein and advanced to the inferior vena cava.The anatomy was not noted to be tortuous or calcified.The user did note that there was resistance at some point during the procedure.The tip of the sheath split when pulling the filter into the sheath.No portion of the device was left within the patient.There was no need for additional procedures or prolonged hospitalization.The patient did not experience any adverse effects due to this occurrence.Corrected information: the following information was available and inadvertently omitted from the last report: investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The distal tip of the sheath was split in two separate places.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu cautions ¿when inserting, manipulating or withdrawing a device through an introducer always maintain introducer position.¿ the ifu also says ¿do not attempt to insert or withdraw the wire guide and/ or introducer if resistance is felt.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a component failure contributed to this failure mode.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information has been received since the last report was submitted.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13419143
• Report Number: 1820334-2022-00150
• Device Sequence Number: 4826059
• Product Code: DYB
• UDI-Device Identifier: 00827002284456
• UDI-Public: (01)00827002284456(17)240809(10)14143844
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2022

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: 08/09/2024
• Device Model Number: G28445
• Device Catalogue Number: RCFW-16.0P-38-45-RB
• Device Lot Number: 14143844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 02/14/2022; 04/26/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 02/21/2022; 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARGON OPTION ELITE FILTER
• Patient Sex: Unknown