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

Model Number	G56232
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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
As reported, during placement of a four-vessel fenestrated endograft for an abdominal aortic aneurysm, the connecting tube/side arm came apart from the hub of a flexor high-flex ansel guiding sheath.The 7 french complaint device was inserted into a cook 22 french extra large check-flo introducer sheath, which had been placed in the groin, for cannulation of the fenestration at the right renal artery.Standard saline was used to prep and flush the device, 50/50 contrast was used for imaging, and heparin was administered during the procedure.The sheath was in place for approximately one-to-two hours, and a covered stent was ready for deployment at the fenestration.At that point, the connection tubing separated from the hub of the sheath.The user placed the connecting tube back into the valve to complete the procedure.Once the fenestration was complete, the complaint device was removed from the 22 french sheath.No piece of the device remained inside the patients body.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects from this event.
Event or Problem Description
There is no new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, during placement of a four-vessel fenestrated endograft for an abdominal aortic aneurysm, the connecting tube/side arm came apart from the hub of a flexor high-flex ansel guiding sheath.The 7 french complaint device was inserted into a cook 22 french extra large check-flo introducer sheath, which had been placed in the groin, for cannulation of the fenestration at the right renal artery.Standard saline was used to prep and flush the device, 50/50 contrast was used for imaging, and heparin was administered during the procedure.The sheath was in place for approximately one-to-two hours, and a covered stent was ready for deployment at the fenestration.At that point, the connection tubing separated from the hub of the sheath.The user placed the connecting tube back into the valve to complete the procedure.Once the fenestration was complete, the complaint device was removed from the 22 french sheath.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, the instructions for use, manufacturing instructions, and quality control data.One used flexor high-flex ansel guiding sheath (kcfw-7.0-35-55-rb-hfanl0-hc) was returned to cook for investigation.The connecting tube was detached from connector cap, and the side arm tubing appeared to have adhesive glue present.Tip damage was also noted.A review of the device history record found no non-conformances related to the reported failure mode.One additional complaint from this product lot was reported from the field for a different failure.As there are 100% inspections to capture this failure mode prior to distribution, and there is objective evidence that the dhr was fully executed, there is objective evidence that the device was manufactured to specification.At this time, cook concluded that no nonconforming product from this lot exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded that component failure unrelated to manufacturing contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook 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.

• 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: 12745843
• Report Number: 1820334-2021-02433
• Device Sequence Number: 14959699
• Product Code: DYB
• UDI-Device Identifier: 00827002562325
• UDI-Public: (01)00827002562325(17)240315(10)13824290
• Combination Product (Y/N): N
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

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: 03/15/2024
• Device Model Number: G56232
• Device Catalogue Number: KCFW-7.0-35-55-RB-HFANL0-HC
• Device Lot Number: 13824290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2021
• 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: 22FR XVCFW COOK SHEATH; 7X22MM V12 STENT; ROSEN WIRE/GLIDE WIRE; VANSCHIE CATHETER; 22FR XVCFW COOK SHEATH.; 7X22MM V12 STENT.; ROSEN WIRE/GLIDE WIRE.; VANSCHIE CATHETER.
• Patient Age: 78 YR
• Patient Sex: Male