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

Model Number	G44155
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned, but the device investigation has yet to be completed.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 an unknown procedure the hub of a flexor ansel guiding sheath separated.The sheath "line" broke causing the hub to separate.No portion of the device was left within the patient.The patient did not require any additional procedures or prolonged hospitalization.No adverse effects to the patient were reported.Additional information has been requested.
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 received on 17aug2021: the separation occurred post-procedure.The nurse was pulling the sheath and the hub separated.They proceeded pulling the sheath and no further complications were noted.No additional procedures needed.No additional details are available for this event.
Additional Manufacturer Narrative
Event summary: as reported, during an unknown procedure the hub of a flexor ansel guiding sheath separated.The sheath "line" broke causing the hub to separate.The separation occurred post-procedure.The nurse was pulling the sheath and the hub separated.They proceeded pulling the sheath and no further complications were noted.No portion of the device was left within the patient.The patient did not require any additional procedures or prolonged hospitalization.No adverse effects to the patient were reported.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record (dhr), the instructions for use, manufacturing instructions, and quality control data.The device was returned.The check-flo body was confirmed to have separated from the sheath.The flare was intact with no evidence of shaft material between the cap and adapter.The cap inner diameter was found to be within specifications.In response to this incident, cook reviewed the dhr.The dhr for the reported complaint device lot records no non-conformances.The dhr for the subassembly lot also records no non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook concluded that no nonconforming product from this lot exists in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control, and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings:: ¿reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.¿ cook concluded that this failure was caused by a component failure unrelated to manufacturing.Per the quality engineering risk assessment, no further action is warranted.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.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
No new patient or event information since the last report was submitted.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12268762
• Report Number: 1820334-2021-01913
• Device Sequence Number: 14532511
• Product Code: DYB
• UDI-Device Identifier: 00827002441552
• UDI-Public: (01)00827002441552(17)231106(10)13538826
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2021

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: 11/06/2023
• Device Model Number: G44155
• Device Catalogue Number: KCFW-7.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 13538826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 08/17/2021; 10/08/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 08/27/2021; 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1