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

Model Number	G44155
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	05/25/2021
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, during treatment of the sfa the hub of a flexor ansel guiding sheath fell off.Access was obtained through the common iliac artery and the sheath was advanced to the sfa.The wire was being advanced again when the hub of the sheath separated, which had been in place for 30 minutes.A catheter had also been advanced through the sheath during the procedure.Another sheath was used to complete the procedure and the patient was able to go home.No portion of the device was left within the patient.No other procedures or prolonged hospitalization were required.No adverse effects were reported due to this occurrence.
Additional Manufacturer Narrative
Event summary: as reported, during treatment of the sfa the hub of a flexor ansel guiding sheath fell off.Access was obtained through the common iliac artery and the sheath was advanced to the sfa.The wire was being advanced again when the hub of the sheath separated, which had been in place for 30 minutes.A catheter had also been advanced through the sheath during the procedure.Another sheath was used to complete the procedure and the patient was able to go home.No portion of the device was left within the patient.No other procedures or prolonged hospitalization were required.No adverse effects were reported due to this occurrence.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, device history record (dhr), manufacturing instructions, quality control data, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be performed.In response to this incident, cook reviewed the dhr.The dhr for the complaint device lot records no non-conformances.The dhr for the associated subassembly lots 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.No 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.Reviews of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.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: precautions: ¿when inserting, manipulating or withdrawing a device through the sheath, always maintain sheath position.¿ how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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: 11979173
• Report Number: 1820334-2021-01497
• Device Sequence Number: 11610040
• Product Code: DYB
• UDI-Device Identifier: 00827002441552
• UDI-Public: (01)00827002441552(17)231231(10)13660793
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 12/31/2023
• Device Model Number: G44155
• Device Catalogue Number: KCFW-7.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 13660793
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1