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

Model Number	G11638
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 procedure involving a stenosed superficial femoral artery via retrograde contralateral femoral access, a flexor raabe guiding sheath separated upon removal of the device.Access into the patient was reportedly difficult, as the femoral access site was calcified and scarred from previous procedures, and resistance was encountered upon insertion of the sheath.There were no problems advancing the sheath over the bifurcation, which was not calcified.The bifurcation angle was normal.An unspecified 0.035-inch amplatz wire guide and unknown balloon were utilized through the sheath during the procedure.The target location was reached and treated successfully.Resistance was encountered upon removal of the sheath, which had been in place for approximately two hours; however, the dilator was not re-inserted prior to removal of the sheath.The sheath shaft separated approximately twenty centimeters from the hub.The user attempted to use an unspecified balloon to remove the separated portion of the sheath; however, this was unsuccessful.The patient was then sent to the operating room, where a vascular surgeon performed an open surgery to remove the separated portion of the sheath.The procedure was successful and the patient is reportedly doing well.According to the initial reporter, 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, unchanged, or unavailable.Summary of event: as reported, during a procedure involving a stenosed superficial femoral artery via retrograde contralateral femoral access, a flexor raabe guiding sheath separated upon removal of the device.Access into the patient was reportedly difficult, as the femoral access site was calcified and scarred from previous procedures, and resistance was encountered upon insertion of the sheath.There were no problems advancing the sheath over the bifurcation, which was not calcified.The bifurcation angle was normal.An unspecified 0.035-inch amplatz wire guide and unknown balloon were utilized through the sheath during the procedure.The target location was reached and treated successfully.Resistance was encountered upon removal of the sheath, which had been in place for approximately two hours; however, the dilator was not re-inserted prior to removal of the sheath.The sheath shaft separated approximately twenty centimeters from the hub.The user attempted to use an unspecified balloon to remove the separated portion of the sheath; however, this was unsuccessful.The patient was then sent to the operating room, where a vascular surgeon performed an open surgery to remove the separated portion of the sheath.The procedure was successful, and the patient is reportedly doing well.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.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 instructions for use (ifu) states ¿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.¿ from the information provided upon review of the customer testimony, dmr, dhr, and ifu, cook concluded that the device was manufactured to specification and no non-conforming devices exists in house or out in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A previously closed capa, addressing susceptibility of ptfe liner damage resulting from handling and processing, resulted in implementation of corrective actions including 100% inspection of bonds, increase in the minimum allowable tensile strength, improvements to the baking process, and a reduction in shelf life for liner raw material.The complaint device was manufactured prior to implementation of the corrective actions.Based on the available information and results of the investigation, cook has concluded that the patient's calcified and scarred anatomy and unintended use error contributed to this event.Access was reportedly difficult due to calcification and scarring at the access site.Additionally, the ifu warns the user to insert the dilator and remove the sheath and dilator as a unit if resistance is anticipated/encountered.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: 17108106
• Report Number: 1820334-2023-00715
• Device Sequence Number: 2174041
• Product Code: DYB
• UDI-Device Identifier: 00827002116382
• UDI-Public: (01)00827002116382(17)260301(10)15247971
• Combination Product (Y/N): N
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2026
• Device Model Number: G11638
• Device Catalogue Number: KCFW-6.0-38-55-RB-RAABE
• Device Lot Number: 15247971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown