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

Model Number	G09810
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an unknown procedure, the hub separated from a flexor introducer sheath.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
E1: phone = (b)(6).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 10dec2025.The procedure was a left tibial artery angioplasty.The issue occurred upon removal of sheath.The access site was right common femoral artery, and the target location was left tibial arteries.The access site was not scarred.The anatomy was not stenosed, tortuous or calcified.Contralateral approach was used.The bifurcation angle was not steep or calcified.A cook's wire guide was used in the lumen of the sheath when the issue occurred.Another manufacturer's balloons were used through the sheath during the procedure.Resistance was not encountered during insertion or removal of sheath or any other devices through the sheath.The sheath hub was used to pull the device from the patient, and the sheath tubing was also gripped during removal.The sheath was removed endovascularly by pulling out of artery dilation.The dilator was not reinserted prior to removal of the sheath.The procedure was completed successfully.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures or experience any adverse effects due to this event.
Additional Manufacturer Narrative
Additional information: b5, d10 and h6 (annexes e & f).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
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 an unknown procedure, the hub separated from a flexor introducer sheath.Additional information was received 10dec2025.The procedure was a left tibial artery angioplasty.The issue occurred upon removal of sheath.The access site was right common femoral artery, and the target location was left tibial arteries.The access site was not scarred.The anatomy was not stenosed, tortuous or calcified.Contralateral approach was used.The bifurcation angle was not steep or calcified.A cook's wire guide was used in the lumen of the sheath when the issue occurred.Another manufacturer's balloons were used through the sheath during the procedure.Resistance was not encountered during insertion or removal of sheath or any other devices through the sheath.The sheath hub was used to pull the device from the patient, and the sheath tubing was also gripped during removal.The sheath was removed endovascularly by pulling out of artery dilation.The dilator was not reinserted prior to removal of the sheath.The procedure was completed successfully.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures or experience any adverse effects due to this event.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.A review of the device history record and complaint history found no relevant discrepancies or additional complaints on the lot.The product ifu instructs ¿remove the sheath.Avoid applying traction to hub during removal.If resistance is anticipated or encountered during withdrawal of the flexor sheath, consider reinserting the dilator and removing 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, and ifu 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 failure to follow instructions contributed to this event.Reportedly, the user removed the device by pulling on the sheath hub and the dilator was not reinserted.The ifu instructs ¿avoid applying traction to hub during removal.If resistance is anticipated or encountered during withdrawal of the flexor sheath, consider reinserting the dilator and removing the sheath and dilator as a unit.¿ 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: FLEXOR INTRODUCER SHEATH
• 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: 23757600
• Report Number: 1820334-2025-01526
• Device Sequence Number: 9934055
• Product Code: DYB
• UDI-Device Identifier: 00827002098107
• UDI-Public: (01)00827002098107(17)280311(10)16503757
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2026

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: G09810
• Device Catalogue Number: KCFW-7.0-38-45-RB
• Device Lot Number: 16503757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 12/10/2025; 03/03/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/12/2025; 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2025
• 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: BOSTON SCIENTIFIC 0.014 COYOTE BALLOON.; BOSTON SCIENTIFIC 0.035 MUSTANG BALLOON.; COOK BENTSON 0.035 180CM.
• Patient Sex: Unknown