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

Model Number G11633

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Cardiac Arrest (1762)

Event Date 08/27/2021

Event Type  Death  

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a procedure involving a chronic total occlusion of a coronary artery, two cook flexor raabe guiding sheaths separated from the hemostatic valves.The patients medical history was significant for coronary artery disease, hypertension, and chronic kidney disease.Reportedly, during routine manipulation, the valve of the first sheath separated as it was inserted into the femoral artery, resulting in bleeding (device associated with this report, patient identifier (b)(6)).The sheath was quickly removed, manually by the physician, and was replaced with another device of the same size and type.The tip of the second sheath (device associated with the report submitted under patient identifier (b)(6)) was placed within the thoracic descending aorta via the right femoral artery.The abdominal aorta was described as tortuous, and an endovascular prosthesis was in place.The sheath was in place for approximately three hours, and unspecified 7 french catheters were used through the sheath during the procedure.During removal of the sheath, the user held the hemostatic valve; however, the valve/hub separated from the sheath without application of traction or force.Resistance was not encountered.The dilator was not reinserted prior to removal of the device, and nothing was within the lumen of the sheath at the time of hub separation.Significant arterial bleeding was reported, requiring intervention.An emergent open surgical approach was required to remove the separated portion of the sheath, performed by the cardio-interventionist team in conjunction with a vascular team.After removing the sheath, but while the patient was still on the surgical table, the patient complained of chest pain and subsequently went into cardiac arrest.The patient was resuscitated after one cycle of cardiopulmonary resuscitation (cpr) and administration of epinephrine.The patient was intubated and sedated and was transferred to the intensive care unit.The patient died the following day.An autopsy was not performed.

Manufacturer Narrative

Summary of event: as reported, during a procedure involving a chronic total occlusion of a coronary artery, two cook flexor raabe guiding sheaths separated from the hemostatic valves.The patient¿s medical history was significant for coronary artery disease, hypertension, and chronic kidney disease.Reportedly, during routine manipulation, the valve of the first sheath separated as it was inserted into the femoral artery, resulting in bleeding (device associated with this report, patient identifier (b)(6)).The sheath was quickly removed, manually by the physician, and was replaced with another device of the same size and type.The tip of the second sheath (device associated with the report submitted under patient identifier (b)(6)) was placed within the thoracic descending aorta via the right femoral artery.The abdominal aorta was described as tortuous, and an endovascular prosthesis was in place.The sheath was in place for approximately three hours, and unspecified 7 french catheters were used through the sheath during the procedure.During removal of the sheath, the user held the hemostatic valve; however, the valve/hub separated from the sheath without application of traction or force.Resistance was not encountered.The dilator was not reinserted prior to removal of the device, and nothing was within the lumen of the sheath at the time of hub separation.Significant arterial bleeding was reported, requiring intervention.An emergent open surgical approach was required to remove the separated portion of the sheath, performed by the cardio-interventionist team in conjunction with a vascular team.After removing the sheath, but while the patient was still on the surgical table, the patient complained of chest pain and subsequently went into cardiac arrest.The patient was resuscitated after one cycle of cardiopulmonary resuscitation (cpr) and administration of epinephrine.The patient was intubated and sedated and was transferred to the intensive care unit.The patient died the following day.An autopsy was not performed.Investigation evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures was conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.No related non-conformances were recorded, and 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.There were no identified gaps in the manufacturing instructions, specifications, or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The product ifu warns, ¿if resistance is encountered during advancement of flexor sheath, assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.If flexor sheath is advanced through resistance, force to remove the sheath will be higher, increasing the risk of sheath material or hub separation upon withdrawal.¿ the ifu also 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 ifu further instructs ¿avoid applying traction to hub during removal.If resistance is anticipated or encountered during withdrawal of the flexor sheath, consider reinserting the dilator and removing the sheath and dilator as a unit.¿ based on the information provided and the results of the investigation, cook has concluded that it is possible that the patient¿s anatomy contributed to this failure mode, as the user facility reported a tortuous abdominal aorta with an endovascular prosthesis in place.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.

Event Description

No additional information has been received since the last report was submitted.

• Brand Name: FLEXOR RAABE GUIDING SHEATH
• Type of Device: 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: 12563435
• MDR Text Key: 274307217
• Report Number: 1820334-2021-02268
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002116337
• UDI-Public: (01)00827002116337(17)240323(10)13841120
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2024
• Device Model Number: G11633
• Device Catalogue Number: KCFW-7.0-38-55-RB-RAABE
• Device Lot Number: 13841120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: KCFW-7.0-38-55-RB-RAABE, LOT 13627916.; KCFW-7.0-38-55-RB-RAABE LOT 13627916
• Patient Outcome(s): Hospitalization; Required Intervention; Death
• Patient Age: 73 YR
• Patient Sex: Male