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

Model Number	G11633
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	07/18/2025
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 a percutaneous coronary angioplasty procedure, the hub of a flexor raabe guiding sheath separated from the device as the physician pulled the sheath back.Access was obtained in the right femoral artery.The access site was not scarred; however, the anatomy was tortuous.Another manufacturer¿s 0.035-inch, 260-centimeter wire was used during the procedure, and another manufacturer¿s 6-french guiding catheter was used through the sheath.Resistance was not encountered during insertion or removal of the sheath or during insertion or removal of any device through the sheath.The dilator was reinserted prior to sheath removal, and the hub was not used to pull the device from the patient.The hub and proximal shaft were outside of the body at the time of hub separation.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
Correction: d4 primary udi summary of event: as reported, during a percutaneous coronary angioplasty procedure, the hub of a flexor raabe guiding sheath separated from the device as the physician pulled the sheath back.Access was obtained in the right femoral artery.The access site was not scarred; however, the anatomy was tortuous.Another manufacturer¿s 0.035-inch, 260-centimeter wire was used during the procedure, and another manufacturer¿s 6-french guiding catheter was used through the sheath.Resistance was not encountered during insertion or removal of the sheath or during insertion or removal of any device through the sheath.The dilator was reinserted prior to sheath removal, and the hub was not used to pull the device from the patient.The hub and proximal shaft were outside of the body at the time of hub separation.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 as well as a customer provided photo was also conducted.The complaint device was returned to cook for investigation.The sheath was pulled free from the hub.There was not any sheath material noted to be left in the hub.A document-based investigation evaluation was performed.A review of the device history record and complaint history found no discrepancies or additional complaints on the lot.The product ifu states, ¿if resistance is encountered during advancement of flexor sheath, assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.If flexor sheath is advanced through resistance, force to remove the sheath will be higher, increasing the risk of sheath material or hub separation upon withdrawal.Reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance is anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.¿ 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 customer supplied photo, returned device, dmr, ifu, and dhr suggests that there is evidence that the device was manufactured to specification.Based on the information provided and the results of the investigation, cook has concluded component failure contributed to this incident.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 RAABE 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: 22714052
• Report Number: 1820334-2025-00932
• Device Sequence Number: 9132786
• Product Code: DYB
• UDI-Device Identifier: 00827002116337
• UDI-Public: (01)00827002116337(17)280130(10)16443884
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 01/28/2026

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: G11633
• Device Catalogue Number: KCFW-7.0-38-55-RB-RAABE
• Device Lot Number: 16443884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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: GUIDING CATH AL1 6FR BOSTON SCIENTIFIC; TERUMO WIRE 035, 260 CM
• Patient Sex: Male