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

Model Number	G12836
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	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an unknown procedure, a flexor shuttle tibial guiding sheath separated at the valve.Additional information has been requested.
Event or Problem Description
Additional information was received on 11dec2025.As reported, during fevar (fenestrated endovascular aortic repair) procedure, the sheath portion of the device separated from the hub with little to no resistance.The issue occurred during insertion via a percutaneous access for "thru and thru wire".The access site was not scarred.The anatomy was not stenosed, tortuous or calcified.Contralateral approach was used.Another manufacturer's wire guide was in the lumen of the sheath when the issue occurred.Resistance was not felt during insertion or removal of the sheath.Resistance was not felt during insertion or removal of any device through the sheath.The sheath was removed endovascularly from the patient.The dilator was not reinserted prior to removal of the sheath.The procedure was completed successfully by replacing with a different unspecified sheath.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
Corrected/additional information: b5, d9, d10 and h6 (annexes e & f).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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an unknown procedure, a flexor shuttle tibial guiding sheath separated at the valve.Additional information was received 11dec2025.As reported, during fevar (fenestrated endovascular aortic repair) procedure, the sheath portion of the device separated from the hub with little to no resistance.The issue occurred during insertion via a percutaneous access for "thru and thru wire".The access site was not scarred.The anatomy was not stenosed, tortuous or calcified.Contralateral approach was used.Another manufacturer's wire guide was in the lumen of the sheath when the issue occurred.Resistance was not felt during insertion or removal of the sheath.Resistance was not felt during insertion or removal of any device through the sheath.The sheath was removed endovascularly from the patient.The dilator was not reinserted prior to removal of the sheath.The procedure was completed successfully by replacing with a different unspecified sheath.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.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The hub was separated from the sheath.The sheath flare was not damaged.A document-based investigation evaluation was performed.A review of the device history record found that one device from the lot lot did not pass quality control inspections; however, the affected product was scrapped prior to release from cook.A review of complaint history found no additional complaints for this lot number.The product ifu states ¿upon removal from package, inspect the product to ensure no damage has occurred¿.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.Although one device from the lot did not pass quality control inspections, the product was scrapped prior to release from cook, there are 100% inspections in place, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that devices manufactured out-of-specification exist in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to manufacturing or design deficiencies, contributed to this event.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 regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FLEXOR SHUTTLE TIBIAL GUIDING 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: 23741593
• Report Number: 1820334-2025-01518
• Device Sequence Number: 15977610
• Product Code: DYB
• UDI-Device Identifier: 00827002128361
• UDI-Public: (01)00827002128361(17)280604(10)16629352
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142819
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2026

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: G12836
• Device Catalogue Number: KSAW-8.0-38-90-RB-SHTL-HC
• Device Lot Number: 16629352
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 03/18/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/06/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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: GLIDEWIRE
• Patient Sex: Unknown