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

Model Number	G08139
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.H3: device evaluation anticipated but not yet begun.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 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
As reported, during a transjugular liver biopsy via access in the jugular vein, the hub of a performer introducer separated upon attempted removal of the device from the patient.Because the physician was unable to grab the sheath with forceps, access was obtained in the common femoral vein (cfv), and the sheath was snared and removed from the cfv.A section of the device did not remain inside the patient¿s body.The patient did not experience any adverse effects due to this event.
Additional Manufacturer Narrative
Additional information: b5, d4, d9, d10.H3: device evaluated by mfg - device evaluation has begun; however, a conclusion is not yet available.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 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
Additional information was received 02oct2025.The anatomy was not scarred, tortuous, or stenosed, and resistance was not encountered during insertion of the sheath.Resistance was not encountered during insertion or removal of a 5-french cook catheter or other manufacturer¿s wire guides through the sheath.The dilator was not reinserted prior to removal of the sheath.Per the reporter, the amount of resistance encountered during sheath removal was not unusual, and nothing was in the sheath lumen at the time of the event.The hub was used to pull the sheath from the patient.There have been no reported adverse effects to the patient.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: as reported, during a transjugular liver biopsy via access in the jugular vein, the hub of a performer introducer separated upon attempted removal of the device from the patient.Because the physician was unable to grab the sheath with forceps, access was obtained in the common femoral vein (cfv), and the sheath was snared and removed from the cfv.A section of the device did not remain inside the patient¿s body.The patient did not experience any adverse effects due to this event.Additional information was received 02oct2025.The anatomy was not scarred, tortuous, or stenosed, and resistance was not encountered during insertion of the sheath.Resistance was not encountered during insertion or removal of a 5-french cook catheter or other manufacturer¿s wire guides through the sheath.The dilator was not reinserted prior to removal of the sheath.Per the reporter, the amount of resistance encountered during sheath removal was not unusual, and nothing was in the sheath lumen at the time of the event.The hub was used to pull the sheath from the patient.There have been no reported adverse effects to the patient.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The hub and side-arm of the complaint device were returned to cook for investigation.The side-arm was attached to the hub.The sheath shaft was not returned.No sheath material remained in the hub.No damage was noted to the silicone disc.A document-based investigation evaluation was performed.A review of the device history record and complaint history found no relevant discrepancies or additional relevant complaints on the lot.The product ifu states ¿insert the introducer dilator over the wire guide into the sheath.Withdraw the sheath and dilator as a unit.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.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.Based on the information provided and the results of the investigation, cook has concluded that unintended user error contributed to this event.The ifu states to withdraw the sheath and dilator as a unit, but the dilator was not reinserted prior to removal of the sheath.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.

• 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: 23116064
• Report Number: 1820334-2025-01173
• Device Sequence Number: 17990557
• Product Code: DYB
• UDI-Device Identifier: 00827002081390
• UDI-Public: (01)00827002081390(17)280317(10)16512946
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K171999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2026

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 Model Number: G08139
• Device Catalogue Number: RCFW-8.0-38-30-RB
• Device Lot Number: 16512946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 10/02/2025; 03/02/2026
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 10/28/2025; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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: 5FR COOK KMP CATHETER.; BOSTON SCIENTIFIC BENTSON WIRE.; TERUMO GLIDEWIRE.
• Patient Sex: Unknown