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

Catalog Number	KCFW-5.0-18/38-45-RB-ANL1-HC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: name and address - line 2: (b)(6).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
As originally reported, upon completion of a procedure involving an angiogram and angioplasty of the leg, a flexor ansel guiding sheath separated at the hub upon attempted removal of the device.The patient was taken to the operating room, where the sheath was surgically removed from the patient.The patient was hospitalized due to the surgical procedure.Upon return and initial evaluation of the device, the sheath material was separated and damaged.The hub was not returned.Additional information has been requested.
Event or Problem Description
Additional information was received 01nov2023.Contralateral access was obtained in the left common femoral artery to target the right superficial femoral artery.The access site was minimally scarred due to previous operations.The "hairpin" aortic bifurcation was steep but not calcified.Another manufacturer's wire guide and other manufacturers' catheters, balloons, and stents were used through the sheath during the procedure.No resistance was felt upon insertion of the complaint sheath; however, resistance was felt during removal of another manufacturer's balloon through the sheath and during sheath exchange with an unspecified short sheath.The dilator was not reinserted prior to removal of the sheath; however, another manufacturer's 0.035-inch wire was in the sheath when the separation occurred.The separated sheath was removed from the patient by surgically opening the common femoral artery and withdrawing the sheath.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as originally reported, upon completion of a procedure involving an angiogram and angioplasty of the leg, a flexor ansel guiding sheath separated at the hub upon attempted removal of the device.The patient was taken to the operating room, where the sheath was surgically removed from the patient.The patient was hospitalized due to the surgical procedure.Upon return and initial evaluation of the device, the sheath material was separated and damaged.The hub was not returned.Additional information was received 01nov2023.Contralateral access was obtained in the left common femoral artery to target the right superficial femoral artery.The access site was minimally scarred due to previous operations.The "hairpin" aortic bifurcation was steep but not calcified.Another manufacturer's wire guide and other manufacturers' catheters, balloons, and stents were used through the sheath during the procedure.No resistance was felt upon insertion of the complaint sheath; however, resistance was felt during removal of another manufacturer's balloon through the sheath and during sheath exchange with an unspecified short sheath.The dilator was not reinserted prior to removal of the sheath; however, another manufacturer's 0.035-inch wire was in the sheath when the separation occurred.The separated sheath was removed from the patient by surgically opening the common femoral artery and withdrawing the sheath.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), 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 separated sheath was accordioned/bunched, starting at approximately 22-centimeters from the distal tip.The separated hub was not returned, and the sheath flare was not present.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional relevant complaints for this lot number.The product ifu states "if resistance is encountered during sheath 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.¿ the ifu also states ¿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.¿ the ifu instructs ¿remove the sheath.Avoid applying traction to hub during removal.If resistance is anticipated or encountered during withdrawal of the flexor sheath, consider reinserting the dilator and removing the sheath and dilator as a unit.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.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.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy and unintended user error contributed to this event.The access site was minimally scarred, and the steep bifurcation was described as ¿hairpin¿.Resistance was encountered upon both removal of another manufacturer¿s balloon from the sheath and upon removal of the sheath for the sheath exchange.Despite meeting resistance, the dilator was not reinserted into the sheath, as suggested in the ifu.Additionally, two bard lifestents were used through the sheath.Although the exact product numbers are unknown, it is possible that either a 5-french or 6-french sheath was required.If a 6-french sheath was required, it is possible that advancement of the lifestents through the 5-french sheath may have caused damage to the sheath which subsequently led to separation; however, this cannot be confirmed with current information.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 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: 17915052
• Report Number: 1820334-2023-01372
• Device Sequence Number: 7472700
• Product Code: DYB
• UDI-Device Identifier: 00827002299818
• UDI-Public: (01)00827002299818(17)260105(10)15148154
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2026
• Device Catalogue Number: KCFW-5.0-18/38-45-RB-ANL1-HC
• Device Lot Number: 15148154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 11/01/2023; 12/13/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/20/2023; 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• 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: 2 AND 5 MM ULTRAVERSE BALLOONS; 6X100 AND 6X150 BARD LIFESTENTS; ANGLED GLIDECATHETER; OMNIFLUSH CATHETER; RADIOFOCUS STIFF GLIDEWIRE .035
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male