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

Model Number	G32194
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an unknown procedure, a flexor introducer sheath leaked at the valve/hub.The user continued to use the device, despite the valve not sealing around an unknown catheter, and blood leaked from the valve.Per the reporter, blood loss was more than usual; however, a blood transfusion was not needed to treat blood loss.No additional interventions were required.Additional information has been requested.
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
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
Additional information received 18nov2021.The access site was described as normal, and the anatomy was not tortuous, calcified, or scarred.An unknown wire and 5 french catheters were used through the sheath, which was in place for forty-five minutes.The case was completed successfully.
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
Event summary: as reported, during an unknown procedure, a flexor introducer sheath leaked at the valve/hub.The user continued to use the device, despite the valve not sealing around an unknown catheter, and blood leaked from the valve.The access site was described as normal, and the anatomy was not tortuous, calcified, or scarred.An unknown wire and 5 french catheters were used through the sheath, which was in place for forty-five minutes.The case was completed successfully.Per the reporter, blood loss was more than usual; however, a blood transfusion was not needed to treat blood loss.No additional interventions were required.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.One used kcfw-5.0-38-30-rb was returned to cook for investigation.The leak was unable to be recreated during testing.A document-based investigation evaluation was performed.One relevant nonconformance was recorded; both affected devices were scrapped.There are 100% inspections to capture this nonconformance.There have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, ¿using the sidearm of the valve, flush the sheath by filling the sheath assembly completely with heparinized saline.¿ based on the available information, cook has concluded that a component failure contributed to this failure mode.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.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.

• Brand Name: FLEXOR INTRODUCER 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: 12788663
• Report Number: 1820334-2021-02476
• Device Sequence Number: 3808077
• Product Code: DYB
• UDI-Device Identifier: 00827002321946
• UDI-Public: (01)00827002321946(17)240520(10)13973599
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2022

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: 05/20/2024
• Device Model Number: G32194
• Device Catalogue Number: KCFW-5.0-38-30-RB
• Device Lot Number: 13973599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 11/18/2021; 03/10/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 11/23/2021; 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2021
• 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
• Patient Age: 68 YR
• Patient Sex: Male