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

Model Number	G29986
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 to treat peripheral artery occlusion in the right leg and using a flexor ansel guiding sheath, the hub cap separated from the sheath.After balloon dilation, the physician began to pull back on the balloon and discovered the check-flo valve had separated, and there was blood leaking out.They used a clip to stop the blood, and then pulled back on the sheath.They changed to another device to continue to treat the lesion below the knee.The patient did not have any tortuous, scarred, or calcified anatomy to note.The sheath was in placed for approximately 20 minutes.The dilator was not in place when the separation occurred.There was resistance felt during insertion or removal.The patient did experience some blood loss, but no need for additional treatment or intervention.No adverse effects to the patient were reported.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d4- lot #, h4, h6: medical device problem code (annex a).Event summary: as reported, during a procedure to treat peripheral artery occlusion in the right leg and using a flexor ansel guiding sheath, the hub cap separated from the sheath.After balloon dilation, the physician began to pull back on the balloon and discovered the check-flo valve had separated, and there was blood leaking out.They used a clip to stop the blood, and then pulled back on the sheath.They changed to another device to continue to treat the lesion below the knee.The patient did not have any tortuous, scarred, or calcified anatomy to note.The sheath was in place for approximately 20 minutes.The dilator was not in place when the separation occurred.There was resistance felt during insertion or removal.The patient did experience some blood loss, but no need for additional treatment or intervention.No adverse effects to the patient were reported.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection and dimensional verification of the device were conducted during the investigation.One used flexor ansel guiding sheath (kcfw-7.0-18/38-45-rb-anl2-hc) was returned to cook for investigation.The hub cap was separated from sheath.There did not appear to be any sheath material in the cap.Forceps marks were apparent approximately 5 mm from the proximal end.The inner diameter of the cap and outer diameter of the sheath measured within specification.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot 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 device is provided with instructions for use which warn, ¿if resistance is encountered during advancement of flexor sheath, assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.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,¿ and, ¿reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance i anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.¿ based on the available information, cook has concluded that user error contributed to this failure mode.It was reported that the dilator was not reinserted into the sheath prior to removal.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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 ANSEL 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: 12789844
• Report Number: 1820334-2021-02479
• Device Sequence Number: 4982601
• Product Code: DYB
• UDI-Device Identifier: 00827002299863
• UDI-Public: (01)00827002299863(17)230901(10)NS13403048
• Combination Product (Y/N): N
• 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: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

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: 11/01/2023
• Device Model Number: G29986
• Device Catalogue Number: KCFW-7.0-18/38-45-RB-ANL2-HC
• Device Lot Number: NS13403048
• 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: 11/01/2021
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 55 KG