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

Model Number	G13338
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 unspecified ¿sinus case¿, a flexor shuttle tibial guiding sheath unraveled.Resistance was encountered upon both insertion and removal of the sheath.As the user attempted to advance a cook stent through the sheath, part of the stent came out of the sheath and part remained stuck inside the sheath.The user was unable to pull the stent back into the sheath.The sheath then started to unravel.The part of the stent that was outside of the sheath then deployed in the patient, while part of the stent remained stuck in the sheath (this event will be reported under patient identifier (b)(6).The user removed the sheath from the patient, and the stent came out with the sheath.The procedure was completed with another cook stent and another manufacturer¿s sheath.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an unspecified ¿sinus case¿, a flexor shuttle tibial guiding sheath unraveled.Resistance was encountered upon both insertion and removal of the sheath.As the user attempted to advance a cook stent through the sheath, part of the stent came out of the sheath and part remained stuck inside the sheath.The user was unable to pull the stent back into the sheath.The sheath then started to unravel.The part of the stent that was outside of the sheath then deployed in the patient, while part of the stent remained stuck in the sheath (this event was reported under patient identifier 426954).The user removed the sheath from the patient, and the stent came out with the sheath.The procedure was completed with another cook stent and another manufacturer¿s sheath.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Correction: d4 investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), 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 found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.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 at the time of manufacture.There is no evidence of non-conforming devices in-house or in the field.A previously closed capa found that the thin wall of the ptfe liner is susceptible to damage from handling and processing during profiling and coil transfer processes; leading to an increased susceptibility to shaft separation.Corrective actions were implemented, including reduction of the ptfe liner shelf-life, improvement of ptfe liner tensile strength, and installation of new oven controllers.The complaint device was manufactured prior to implementation of the corrective actions.Based on the information provided and the results of the investigation, cook has concluded that a manufacturing deficiency contributed to this event; however, the complaint device was manufactured prior to implementation of corrective actions resulting from a previously completed capa.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 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: 19221983
• Report Number: 1820334-2024-00594
• Device Sequence Number: 20558893
• Product Code: DYB
• UDI-Device Identifier: 00827002133389
• UDI-Public: (01)00827002133389(17)241122(10)14370350
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K142819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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 Expiration Date: 11/22/2024
• Device Model Number: G13338
• Device Catalogue Number: KSAW-7.0-38-80-RB-SHTL-HC
• Device Lot Number: 14370350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• 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: ANGIOSEAL; COOK BARE METAL STENT; COOK G50171-ZIB6-35-125-8-100; UNKNOWN LONG SHEATH
• Patient Sex: Unknown