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

Model Number	G13264
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address: phone: (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a procedure involving the carotid artery via access in the superficial femoral artery, a flexor shuttle tibial guiding sheath separated at the hub upon removal of the device.The femoral access site was reportedly very fibrotic from a previous bypass procedure, as were the femoral and proximal right iliac arteries.Tension was reported upon removal of the sheath, which was inserted to 90 centimeters.The dilator was not in place upon removal of the sheath, which separated at the junction with the valve upon difficult removal from the patient.The device was completely removed from the patient.Heparin was given during the procedure; however, blood loss was not reported.The patient's current status was reported to be, "ok." 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.
Additional Manufacturer Narrative
Summary of event: as reported, during a procedure involving the carotid artery via access in the superficial femoral artery, a flexor shuttle tibial guiding sheath separated at the hub upon removal of the device.The femoral access site was reportedly very fibrotic from a previous bypass procedure, as were the femoral and proximal right iliac arteries.Tension was reported upon removal of the sheath, which was inserted to 90 centimeters.The dilator was not in place upon removal of the sheath, which separated at the junction with the valve upon difficult removal from the patient.The device was completely removed from the patient.Heparin was given during the procedure; however, blood loss was not reported.The patient's status was reported to be, "ok." 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.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, 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.No related non-conformances were found, and there have been no other reported complaints for this lot number.From the information provided upon review of the dmr, dhr, dhf, and ifu, cook concluded that the device was manufactured to specification, and that there are no nonconforming devices in house or out in the field.The product ifu warns, "reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation." cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a component failure without design or manufacturing deficiency contributed to the failure mode.The customer stated that the patient anatomy was fibrous, and that the dilator was not inserted when the separation occurred.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
• MDR Report Key: 10938688
• Report Number: 1820334-2020-02228
• Device Sequence Number: 4559876
• Product Code: DYB
• UDI-Device Identifier: 00827002132641
• UDI-Public: (01)00827002132641(17)230812(10)13363120
• Combination Product (Y/N): N
• PMA/510(K) Number: K142819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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: 08/12/2023
• Device Model Number: G13264
• Device Catalogue Number: KSAW-6.0-38-90-RB-SHTL-HC
• Device Lot Number: 13363120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO GUIDEWIRE, UNKNOWN CAROTID STENT.; TERUMO GUIDEWIRE, UNKNOWN CAROTID STENT