MAUDE Adverse Event Report: COOK INC CHECK-FLO EXTRA LARGE INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer (person): (b)(6).Pma/510(k): preamendment.(b)(4).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
It was reported that a check-flo extra large introducer was leaking through the valve during a standard fenestrated case.The procedure involved 4 fenestrated cmd grafts in the thoracic aorta.A 7 french ansel sheath and 3 wires, a lunderquist, an amplatz, and a rosen wire, were also used during the case.The check-flo valve was reportedly punctured in the "usual manner" to allow fenestration cannulation, however the valve still leaked.The patient experienced "sufficient blood loss" and required a blood transfusion.Additional information regarding patient and event information has been requested but is not currently available.
Event or Problem Description
Additional information was received on 07oct2020.It was reported that "3 x 6fr ansel sheaths" were placed through the check-flo valve during the procedure.The procedure was "finished ok, completed as normal" and the patient was described to be "doing well.".
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.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation on (b)(6) 2020, cook became aware of an incident where during a procedure, a check-flo extra large introducer (rpn: xvcfw-20.0-35-25, lot: 10118988) was leaking, resulting in blood loss.The issue was reported by a physician at st georges healthcare in united kingdom.A blood transfusion was required to treat the patient.A review of documentation including the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions (mi), quality control, and specifications, as well as a visual inspection of the returned device, was conducted during the investigation.One used device was returned to cook for evaluation.Upon visual inspection, no visible damage was noted.A leak test found that the captor valve had a slow leak when the dilator was inserted, but did not leak without it.Cook has concluded that the device was manufactured to specifications.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (10118988) and the related graft subassembly lots revealed two related non-conformances for "incorrect slit in the disc" and "tear in the valve disc" in which the affected devices were identified and scrapped prior to distribution.A database search did not identify any other events associated with the reported device lot.As there are adequate inspection activities in place, objective evidence that the dhr was fully executed, no related non-conformances, and no other lot-related complaints received from the field, cook has concluded that there is no evidence that non-conforming product exists either in house or in the field.Cook also reviewed product labeling.The product ifu, t_intro_rev6 ¿introducers,¿ provides the following information to the user related to the reported failure mode: ¿precautions: - the maximum diameter of the instrument or catheter to be introduced should be determined to ensure its passage through the introducer.All instruments or catheters used with this product should move freely through the valve and sheath.Damage to the valve/introducer may result when the fit is tight.- when inserting, manipulating or withdrawing a device through an introducer always maintain introducer position.Instructions for use sheath introduction 1.Upon removal from package, ensure the inner diameter (id) of the introducer is appropriate for the maximum diameter of the instrument or catheter to be introduced.How supplied upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of the returned product, and the results of the investigation, a potential root cause for this event has been traced to component failure of the introducer hemostasis valve.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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.

• Brand Name: CHECK-FLO EXTRA LARGE INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10574327
• Report Number: 1820334-2020-01738
• Device Sequence Number: 14236451
• Product Code: DYB
• UDI-Device Identifier: 00827002289994
• UDI-Public: (01)00827002289994(17)221030(10)10118988
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2021

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: 10/30/2022
• Device Model Number: N/A
• Device Catalogue Number: XVCFW-20.0-35-25
• Device Lot Number: 10118988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 10/07/2020; 02/09/2021
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/13/2020; 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3 X 6FR ANSEL SHEATHS; 4 FENESTRATED CMD GRAFTS; 7 FR ANSEL SHEATH; AMPLATZ WIRE; LUNDERQUIST WIRE; ROSEN WIRE; 4 FENESTRATED CMD GRAFTS; 7 FR ANSEL SHEATH; AMPLATZ WIRE; LUNDERQUIST WIRE; ROSEN WIRE
• Outcome Attributed to Adverse Event: Required Intervention