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

Model Number	G29982
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during an ael procedure of the left iliac and femoral arteries via contralateral access from the right femoral artery, a flexor ansel guiding sheath unraveled and separated.The sheath became stuck, and the physician used force to remove it, at which point the sheath unraveled and separated.A fragment including the radiopaque band remained in the patient and was therefore stented against the artery wall.An open surgical procedure was performed on the right femoral access site to repair the arterial damage that occurred during removal of the sheath.According to the initial reporter, the patient did not experience any adverse effects due to this event.Additional information has been requested.
Additional Manufacturer Narrative
Initial reporter name and address: customer name and address= phone: (b)(6).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 "ael" procedure of the left iliac and femoral arteries via contralateral access from the right femoral artery, a flexor ansel guiding sheath unraveled and separated.The sheath became stuck, and the physician used force to remove it, at which point the sheath unraveled and separated.A fragment including the radiopaque band remained in the patient and was therefore stented against the artery wall.An open surgical procedure was performed on the right femoral access site to repair the arterial damage that occurred during removal of the sheath.According to the initial reporter, the patient did not experience any adverse effects due to this event.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 24.7-centimeters from the hub.The inner coil was exposed, unraveled, and elongated.A document-based investigation evaluation was performed.No related non-conformances were found, and there were no other relevant complaints on the lot.The product ifu states that reinsertion of the dilator prior to removal of the sheath increases the strength of the sheath and lessens the risk of device separation and suggests insertion of the dilator prior to removal if resistance is encountered or anticipated during withdrawal of the device.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 was unable to establish a cause for this event.The risk analysis for this failure mode was reviewed and no additional escalation was required.There is currently a capa investigation open to investigate this product failure.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: 15663167
• Report Number: 1820334-2022-01654
• Device Sequence Number: 14947072
• Product Code: DYB
• UDI-Device Identifier: 00827002299825
• UDI-Public: (01)00827002299825(17)250616(10)14798618
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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: 06/16/2025
• Device Model Number: G29982
• Device Catalogue Number: KCFW-6.0-18/38-45-RB-ANL1-HC
• Device Lot Number: 14798618
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female