MAUDE Adverse Event Report: COOK INC UNKNOWN; Catheter, intravascular, diagnostic

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Type  Death  

Manufacturer Narrative

Common name & product code = unavailable as the device lot number, rpn, and gpn are unknown.Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown.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 in the literature by davis et al.(2019), a patient with ehlers-danlos syndrome (eds) type iv underwent an endovascular procedure, during which an unspecified 5 french ¿h1¿ cook catheter was used.Per the authors, eds is an inherited connective tissue disorder that results in poor integrity of blood vessels.It is associated with catastrophic arterial bleeding.The authors state that the ¿present report describes a power-injection arterial injury¿.The patient presented with an acute abdomen, elevated heart rate, and low blood pressure.The patient¿s hemoglobin and hematocrit were also low.A ct scan noted a 1.35-centimeter pseudoaneurysm in the proximal superior mesenteric artery (sma) as well as blood in the peritoneum.It was decided that the patient would undergo an endovascular intervention.Another manufacturer¿s 5 french sheath and an unspecified 4 french cook pigtail catheter were advanced into the lower thoracic aorta via a transfemoral approach.A diagnostic angiogram was performed with 30-milliliters of contrast, at a contrast injection rate of 15-milliliters per second.The superior mesenteric artery was then engaged with an unspecified cook 5 french ¿h1¿ catheter.A lateral angiogram was obtained, using 10-milliliters of contrast at a rate of 3-milliliters per second, noting a pseudoaneurysm near the sma origin with distal occlusion.Another angiogram was obtained, without any manipulation of the wire guide or catheter, using 10-milliliters of contrast at a rate of 1.5-milliliters per second.Contrast extravasation was noted at the mid-sma.The patient¿s hemodynamic status further deteriorated.The patient was taken to the operating room for an emergent laparotomy.General anesthesia was given, and a midline laparotomy was made.Blood was noted in the peritoneal cavity.Initial supraceliac aortic control was attempted to allow for aggressive resuscitation.After stabilization, definitive retroperitoneal supraceliac was attempted, during which the celiac artery pulled away from the aorta.The physician was unable to reattach the celiac artery due to a lack of aortic wall integrity and inability of the aorta to hold the sutures.The supraceliac aorta then became disrupted.The patient went into cardiac arrest.Chest compressions were performed, but the patient died from unsalvageable visceral aortic disruption.The authors conclude that engaging/manipulation of the sma and the force of contrast injection while using a power injector may have caused the arterial injury.Reference for article: davis, j.R., kiang, s.C, dudley, k.M., patel, s.T., smith, j.C., tomihama, r.T.(2019).Power-injector injury in a patient with ehlers-danlos syndrome.Jvir 30(10), p.1685-87.Doi: https://doi.Org/10.1016/j.Jvir.2019.04.005.There has been no alleged malfunction of the cook device.

Event Description

Additional information was received 28jun2022, confirming that the cook device did not malfunction.Per the user, the event occurred due to extremely fragile, friable vasculature from the underlying patient condition.The procedure was considered high-risk and was performed due to the patient's emergent condition at the time of the event.Per the user, rupture was not anticipated, but is a well known complication, regardless of the type of catheter used, in this patient population.

Manufacturer Narrative

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.

Manufacturer Narrative

Summary of event: as reported in the literature by davis et al.(2019), a patient with ehlers-danlos syndrome (eds) type iv died subsequent to an endovascular procedure during which an unspecified 5 french ¿h1¿ cook catheter was used.Per the user, the cook device did not malfunction.Per the user, the event occurred due to extremely fragile, friable vasculature from the underlying patient condition.The procedure was considered high-risk and was performed due to the patient's emergent condition at the time of the event.Per the user, rupture was not anticipated, but is a well-known complication, regardless of the type of catheter used, in this patient population.Investigation evaluation: reviews of the instructions for use (ifu) and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.Cook completed a review of the product device master record (dmr).Cook could not complete a review of the device history record (dhr), due to lack of lot information from the user facility.A global shipment search for all devices the reporting customer has bought in the past 3 years was performed but could not definitively determine the lot number of the complaint device.The product ifu states, ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of the article, dmr, and ifu 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.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy and condition/diagnosis contributed to this event.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: UNKNOWN
• Type of Device: Catheter, intravascular, diagnostic
• 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: 14497071
• MDR Text Key: 292689816
• Report Number: 1820334-2022-00972
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 4FR COOK PIGTAIL CATHETER; 5FR TERUMO SHEATH
• Patient Outcome(s): Death
• Patient Age: 14 YR
• Patient Sex: Male