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

Model Number	G12835
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	10/23/2024
Type of Reportable Event	Malfunction
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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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 transluminal angioplasty of the superficial femoral artery via contralateral antegrade access in the right femoral artery, the hub of a flexor shuttle tibial guiding sheath separated upon insertion and advancement of the device.The device had been stored stacked in the box, and the package was not damaged.The anatomy was reportedly calcified, with "strong calcification" in the terminal aorta.A ¿little¿ resistance was noted during insertion and/or removal of the device over another manufacturer's 0.035 inch, 260 centimeter wire, but "nothing that interfered." the device came apart/separated at the junction of the sheath and hub.Reportedly, during advancement to the "distal side", it "broke" with the dilator.The dilator was not damaged.Sharp edges were not noted.The complaint device was replaced with another manufacturer's 7 french sheath, and the procedure was completed.A section of the device did not remain inside the patient¿s body.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 percutaneous transluminal angioplasty of the superficial femoral artery via contralateral antegrade access in the right femoral artery, the hub of a flexor shuttle tibial guiding sheath separated upon insertion and advancement of the device.The device had been stored stacked in the box, and the package was not damaged.The anatomy was reportedly calcified, with ¿strong calcification¿ in the terminal aorta.A ¿little¿ resistance was noted during insertion and/or removal of the device over another manufacturer¿s 0.035-inch, 260-centimeter wire, but ¿nothing that interfered.¿ the device came apart/separated at the junction of the sheath and hub.Reportedly, during advancement to the ¿distal side¿, it ¿broke¿ with the dilator.The dilator was not damaged.Sharp edges were not noted.The complaint device was replaced with another manufacturer¿s 7-french sheath, and the procedure was completed.A section of the device did not remain inside the patient¿s body.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 (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 shaft of the sheath.The sheath was buckled, and the tip was slightly out-of-round.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.The product ifu states ¿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.¿ 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.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s calcified anatomy likely contributed to this event.Although it is also possible that user technique related to application of force to the hub may have contributed to the event, this cannot be definitively determined.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: 20674368
• Report Number: 1820334-2024-01476
• Device Sequence Number: 8304438
• Product Code: DYB
• UDI-Device Identifier: 00827002128354
• UDI-Public: (01)00827002128354(17)260627(10)15507605
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 06/27/2026
• Device Model Number: G12835
• Device Catalogue Number: KSAW-7.0-38-90-RB-SHTL-HC
• Device Lot Number: 15507605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO/RADIFOCUS 0.035 INCH 260 CM WIRE GUIDE
• Patient Sex: Unknown