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

Model Number	G56231
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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.
Event or Problem Description
As reported, during an unspecified procedure, a flexor high-flex ansel guiding sheath was difficult to remove from the patient.Reportedly, the sheath and dilator were inserted over an unknown wire and advanced over the steep bifurcation.The dilator was removed, and the user noted that the sheath kinked at the bifurcation.In addition to the bifurcation being steep, an area of heavy calcium was noted at the right aortic bifurcation.The physician attempted to reinsert the dilator but was unable to do so because of the kink.A vascular surgeon was called to assist in removal of the sheath, and the dilator was then able to be advanced by torqueing the dilator and wire guide.The sheath was then pushed up into the aorta and was able to be removed.The case was not completed; however, it is unknown why.Per the reporter, there was no harm to the patient.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 information has been requested.
Event or Problem Description
Additional information was received 17may2022 and was inadvertently omitted from the initial report.The bifurcation was acute, and the patient had a chunk of calcium at the ostium of the right common iliac artery.The physician was unable to complete the case.The patient was brought back a few days later, and another manufacturer's sheath was used without issue.Upon return and initial evaluation of the device, the sheath appeared to be flattened.
Additional Manufacturer Narrative
H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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.
Event or Problem Description
No additional information has been received since the last report was submitted.
Additional Manufacturer Narrative
Summary of event: as reported, during an unspecified procedure, a flexor high-flex ansel guiding sheath was difficult to remove from the patient.Reportedly, the sheath and dilator were inserted over an unknown wire and advanced over the steep/acute bifurcation.The patient had a chunk of calcium at the ostium of the right common iliac artery.The dilator was removed, and the user noted that the sheath kinked at the bifurcation.In addition to the bifurcation being steep, an area of heavy calcium was noted at the right aortic bifurcation.The physician attempted to reinsert the dilator but was unable to do so because of the kink.A vascular surgeon was called to assist in removal of the sheath, and the dilator was then able to be advanced by torquing the dilator and wire guide.The sheath was then pushed up into the aorta and was able to be removed.The case was not completed; however, it is unknown why.Per the reporter, there was no harm to the patient.The patient was brought back a few days later, and another manufacturer's sheath was used without issue.Upon return and initial evaluation of the device, the sheath appeared to be flattened.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), dimensional verification, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The sheath was flattened, starting at 30.5-centimeters from the white cap and extending to 50-centimeters from the white cap.The length of the sheath was measured to be slightly longer than specification, though this discrepancy is likely caused by the flattening of the sheath.A document-based investigation evaluation was performed.No related non-conformances were found.One additional complaint was found on the lot for an unrelated failure mode.The product ifu states ¿remove the wire guide and dilator, then aspirate and flush through the sheath side-arm.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy/condition contributed to this incident, as the bifurcation was steep, and a heavy piece of calcium was noted at the right aortic bifurcation.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.

• Brand Name: FLEXOR HIGH-FLEX 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: 14489250
• Report Number: 1820334-2022-00959
• Device Sequence Number: 4809127
• Product Code: DYB
• UDI-Device Identifier: 00827002562318
• UDI-Public: (01)00827002562318(17)250302(10)14572415
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2022

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: 03/02/2025
• Device Model Number: G56231
• Device Catalogue Number: KCFW-6.0-35-55-RB-HFANL0-HC
• Device Lot Number: 14572415
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 05/17/2022; 08/26/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 06/09/2022; 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Male