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	05/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an unknown procedure, the hub of a flexor ansel guiding sheath separated upon removal of the device from the patient.Considerable force was not applied to the hub at the time of the event.The sheath was removed from the patient in its entirety.Additional information has been requested.
Additional Manufacturer Narrative
Customer name and address = postal code: (b)(6); line 2: (b)(6).Occupation = angiography tech / inventory control.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
Additional information was received 25may2022.The procedure was a transfemoral arteriogram of the left leg, via retrograde contralateral right common femoral access, with angioplasty and stenting for critical limb ischemia.Ultrasound guidance was used for access.Standard resistance was reported during insertion, due to the presence of a fibrotic scar at the right groin access site, requiring serial dilation.The sheath was removed at the end of the case, and nothing was in the lumen at the time of separation.The dilator was not reinserted prior to device removal.Per the user, the entire sheath was held and pulled from the groin in standard fashion, but given the scarred groin and resistance, the hub separated.Direct pressure was applied for fifteen minutes.No hematoma was noted.The procedure was completed successfully.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
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary: as reported, the hub of a flexor ansel guiding sheath separated upon removal of the device from the patient.Considerable force was not applied to the hub at the time of the event.The sheath was removed from the patient in its entirety.The procedure was a transfemoral arteriogram of the left leg, via retrograde contralateral right common femoral access, with angioplasty and stenting for critical limb ischemia.Ultrasound guidance was used for access.Standard resistance was reported during insertion, due to the presence of a fibrotic scar at the right groin access site, requiring serial dilation.The sheath was removed at the end of the case, and nothing was in the lumen at the time of separation.The dilator was not reinserted prior to device removal.Per the user, the entire sheath was held and pulled from the groin in standard fashion, but given the scarred groin and resistance, the hub separated.Direct pressure was applied for fifteen minutes.No hematoma was noted.The procedure was completed successfully.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 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.One flexor ansel guiding sheath was received in a used condition.The flare of the sheath came out of white cap of the hub and was oval shaped.A dimensional verification of the inner diameter of the sheath could not be conducted due to the damage.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 instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings ¿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.Reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance is anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.¿ cook has concluded that unintended use error and patient condition contributed to this incident.During the removal of the sheath the user did not reinsert the dilator into the sheath.The patient anatomy was also noted as being scarred and requiring serial dilation to place the sheath.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 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 ; 8128294891
• MDR Report Key: 14396720
• Report Number: 1820334-2022-00714
• Device Sequence Number: 14783760
• Product Code: DYB
• UDI-Device Identifier: 00827002441552
• UDI-Public: (01)00827002441552(17)250120(10)14486792
• Combination Product (Y/N): N
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2022

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: 01/20/2025
• Device Model Number: G44155
• Device Catalogue Number: KCFW-7.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 14486792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 05/25/2022; 06/29/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 06/03/2022; 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MUSTANG BALLOON
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 48 KG