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

Model Number	G30009
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
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.
Event or Problem Description
As reported, after the procedure was completed and upon removal of the flexor shuttle tibial guiding sheath, the sheath separated.Access was gained through the groin., and it was in place for about one hour.A wire guide was inside of the lumen when the separation occurred.No additional medications or blood products were used during the procedure.It was reported that the patient had scarred anatomy.The separation occurred at the shaft, but everything was retrieved, and nothing was left inside of the patient.The patient was noted to be fine, and the procedure had a successful outcome.No unintended portion of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.
Additional Manufacturer Narrative
The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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
Additional information was provided on 17feb2021: the procedure being performed was a brachial thrombectomy.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, after the brachial thrombectomy procedure was completed and upon removal of the flexor shuttle tibial guiding sheath, the sheath separated.Access was gained through the groin, and the sheath was in place for about one hour.A wire guide was inside of the lumen when the separation occurred.No additional medications or blood products were used during the procedure.It was reported that the patient had scarred anatomy.The separation occurred at the shaft, but everything was retrieved, and nothing was left inside of the patient.The patient was noted to be fine, and the procedure had a successful outcome.No unintended portion of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the 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.A visual inspection of the complaint device was also conducted.Physical examination of the used returned device noted that the sheath had separated 22cm from the hub.Coils were exposed but not separated.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.Evidence from the complaint file, device history record, complaint history, manufacturing documents, and device failure analysis suggests that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The product ifu instructs the user to inspect the product to ensure no damage has occurred upon removal from the package, and to reinsert the dilator prior to removal if resistance is expected.Based on the information provided and the results of the investigation, cook has concluded that device failure contributed to the event.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: 11314756
• Report Number: 1820334-2021-00315
• Device Sequence Number: 4078866
• Product Code: DYB
• UDI-Device Identifier: 00827002300095
• UDI-Public: (01)00827002300095(17)210725(10)9045902
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K142819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2021

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: 07/25/2021
• Device Model Number: G30009
• Device Catalogue Number: KSAW-5.0-18/38-90-RB-SHTL-HC
• Device Lot Number: 9045902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 02/17/2021; 05/06/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 02/22/2021; 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1