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

Catalog Number	KCFW-6.0-18/38-45-RB-ANL0-HC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Unspecified Heart Problem (4454)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during an unspecified procedure, a flexor ansel guiding sheath separated in the left common iliac artery upon removal of the device.Access was obtained in the right groin and a contralateral approach was used to treat the left superficial femoral artery.The anatomy was both tortuous and calcified.It is believed that powdered gloves were worn.The hydrophilic coating was activated with normal saline.Another manufacturer's wire guide was used during the procedure.Some of the hydrophilic coating from the other manufacturer's wire guide, which was in the lumen of the complaint device, reportedly separated from the wire and was removed from the patient prior to sheath separation.Resistance was encountered upon removal of the sheath over the other manufacturer's wire, and the sheath reportedly separated approximately ten centimeters from the distal tip, with the dilator in place.Reportedly, a cut-down of the left brachial artery was performed, and an unspecified 11-french sheath, 10-french catheter, and other manufacturer's snare were used to retrieve the separated sheath as well as the other manufacturer's wire coating.An unspecified "cardiac response" occurred, resulting in administration of vasopressors.Per the reporter, the patient had an extensive cardiac history.The procedure, which took place in an outpatient facility, took approximately 2.5 hours longer than expected.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 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 reported, during an unspecified procedure, a flexor ansel guiding sheath separated in the left common iliac artery upon removal of the device.Access was obtained in the right groin and a contralateral approach was used to treat the left superficial femoral artery.The anatomy was both tortuous and calcified.It is believed that powdered gloves were worn.The hydrophilic coating was activated with normal saline.Another manufacturer's wire guide was used during the procedure.Some of the hydrophilic coating from the other manufacturer's wire guide, which was in the lumen of the complaint device, reportedly separated from the wire and was removed from the patient prior to sheath separation.Resistance was encountered upon removal of the sheath over the other manufacturer's wire, and the sheath reportedly separated approximately ten centimeters from the distal tip, with the dilator in place.Reportedly, a cut-down of the left brachial artery was performed, and an unspecified 11-french sheath, 10-french catheter, and other manufacturer's snare were used to retrieve the separated sheath as well as the other manufacturer's wire coating.An unspecified "cardiac response" occurred, resulting in administration of vasopressors.Per the reporter, the patient had an extensive cardiac history.The procedure, which took place in an outpatient facility, took approximately 2.5 hours longer than expected.Investigation evaluation: reviews of the complaint history, device history record, 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 sheath was separated approximately 29.3-centimeters from the hub.The sheath was damaged and compressed at the point of separation.A document-based investigation evaluation was performed.No related non-conformances or additional complaints were found on the final lot.One relevant non-conformance was noted on the sheath sub-assembly lot; however, all affected product was scrapped and there are 100% inspections in place to capture the non-conformance.No additional complaints have been received for devices with the same sheath sub-assembly lot.The product ifu 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 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.Although one relevant non-conformance was noted on a sub-assembly lot, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that additional non-conforming product exists 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 contributed to this event, as the anatomy was both tortuous and calcified.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: 17398859
• Report Number: 1820334-2023-00964
• Device Sequence Number: 12655337
• Product Code: DYB
• UDI-Device Identifier: 00827002441545
• UDI-Public: (01)00827002441545(17)260411(10)15381412
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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: 04/11/2026
• Device Catalogue Number: KCFW-6.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 15381412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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: MERIT SPLASHWIRE, N-SNARE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male