MAUDE Adverse Event Report: COOK INC BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

Catalog Number UNKNOWN

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

Patient Problems Stroke/CVA (1770); Death (1802)

Event Type  Death  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Common name & product code = unavailable as the device lot number, rpn, and gpn are unknown.Concomitant medical products= merit medical 5 french pigtail catheter, direxion hi-flow 0.021 inch microcatheter from boston scientific, embosphere particles from biosphere medical.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, a (b)(6) female patient with a large solitary fibrous tumor of the pleura (sftp) in the right chest wall underwent a preoperative angiogram with embolization, during which an unspecified 5 french beacon tip torcon nb advantage angiographic catheter was used, in preparation for surgical removal of the tumor.A mri of the chest confirmed the sftp, allowing visualization of the diaphragm and excluding invasion of surrounding structures.It showed majority of the blood supply originating from the abdominal aorta.The complaint device was used to select the proximal right brachiocephalic artery for arteriography demonstrating no evidence of significant supply from the axillary, long thoracic, lateral thoracic, or internal mammary arteries.Another manufacturer's 5 french pigtail catheter was then used for an aortogram, which showed a markedly enlarged and tortuous right inferior phrenic artery supplying the tumor, followed by selective catheterization and angiography of the right inferior phrenic artery using the original 5f cook catheter.Another manufacturer's 0.021 inch microcatheter was used to advance more distally in the right phrenic artery to deploy 4 vials of 500¿700 micrometer embolization particles until stasis was achieved.During the procedure, the patient complained of right hand pain but displayed no weakness as she continued to move her arms and required restraint.Her speech began to slur and eyes deviated to the right.The patient eventually went into respiratory failure and required emergent intubation.An mri obtained later in the day showed numerous sizable areas of embolic infarction throughout both cerebral and cerebellar hemispheres.The family withdrew care, and the patient passed the next day.The authors explain that the sftp was supplied by the right inferior phrenic artery with tangle of numerous intra-tumoral blood vessels and no clear visualization of the venous drainage.The authors explore possible reasons for the diffuse embolic strokes in this case, including the possibility that the sftp had an intra-tumoral shunt and an aberrant pulmonary venous drainage, which allowed particles to rapidly transit the tumor and shunt to the brain.Two additional explanations include (1) intra-tumoral shunt with patent foramen ovale and (2) intra-tumoral shunt with pulmonary avms.According to the authors, given the immediate symptoms and large areas of bilateral anterior and posterior brain circulation involvement, pulmonary venous drainage is most likely.The patient had no reported history of pfo or imaging characteristics of pulmonary avms.In this instance, the authors discuss that tortuous arterial anatomy did not allow them to introduce the diagnostic catheter deep into the inferior phrenic artery, which limited their ability to perform high volume angiogram and evaluate both the arterial and venous anatomy.The authors state that in hindsight, femoral access may have resulted in a better chance at advancing the catheter more distally and performing high volume angiogram.The authors conclude that in cases with large tumors, such as this one, significant venous drainage should be expected and evaluated by large volume angiogram of the tumor.There has been no alleged malfunction of any cook device.Reference for literature article: patel, s.R., vachhani, p., moeslein, f.(2017).Embolic brain infarcts: a rare fatal complication of preoperative embolization of a massive solitary fibrous tumor of the pleura.Cardiovascular and interventional radiology, 40.Doi 10.1007/s00270-016-1501-4.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Initial report as reported in the literature, a 69 year-old female patient with a large solitary fibrous tumor of the pleura (sftp) in the right chest wall underwent a preoperative angiogram with embolization, during which an unspecified 5 french beacon tip torcon nb advantage angiographic catheter was used, in preparation for surgical removal of the tumor.A mri of the chest confirmed the sftp, allowing visualization of the diaphragm and excluding invasion of surrounding structures.It showed majority of the blood supply originating from the abdominal aorta.The complaint device was used to select the proximal right brachiocephalic artery for arteriography demonstrating no evidence of significant supply from the axillary, long thoracic, lateral thoracic, or internal mammary arteries.Another manufacturer's 5 french pigtail catheter was then used for an aortogram, which showed a markedly enlarged and tortuous right inferior phrenic artery supplying the tumor, followed by selective catheterization and angiography of the right inferior phrenic artery using the original 5f cook catheter.Another manufacturer's 0.021 inch microcatheter was used to advance more distally in the right phrenic artery to deploy 4 vials of 500¿700 micrometer embolization particles until stasis was achieved.During the procedure, the patient complained of right hand pain but displayed no weakness as she continued to move her arms and required restraint.Her speech began to slur and eyes deviated to the right.The patient eventually went into respiratory failure and required emergent intubation.An mri obtained later in the day showed numerous sizable areas of embolic infarction throughout both cerebral and cerebellar hemispheres.The family withdrew care, and the patient passed the next day.The authors explain that the sftp was supplied by the right inferior phrenic artery with tangle of numerous intra-tumoral blood vessels and no clear visualization of the venous drainage.The authors explore possible reasons for the diffuse embolic strokes in this case, including the possibility that the sftp had an intra-tumoral shunt and an aberrant pulmonary venous drainage, which allowed particles to rapidly transit the tumor and shunt to the brain.Two additional explanations include (1) intra-tumoral shunt with patent foramen ovale and (2) intra-tumoral shunt with pulmonary avms.According to the authors, given the immediate symptoms and large areas of bilateral anterior and posterior brain circulation involvement, pulmonary venous drainage is most likely.The patient had no reported history of pfo or imaging characteristics of pulmonary avms.In this instance, the authors discuss that tortuous arterial anatomy did not allow them to introduce the diagnostic catheter deep into the inferior phrenic artery, which limited their ability to perform high volume angiogram and evaluate both the arterial and venous anatomy.The authors state that in hindsight, femoral access may have resulted in a better chance at advancing the catheter more distally and performing high volume angiogram.The authors conclude that in cases with large tumors, such as this one, significant venous drainage should be expected and evaluated by large volume angiogram of the tumor.There has been no alleged malfunction of any cook device.Reference for literature article: patel, s.R., vachhani, p., moeslein, f.(2017).Embolic brain infarcts: a rare fatal complication of preoperative embolization of a massive solitary fibrous tumor of the pleura.Cardiovascular and interventional radiology, 40.Doi 10.1007/s00270-016-1501-4 investigation - evaluation reviews of the complaint history, manufacturer¿s instructions, drawing, instructions for use (ifu), and quality control were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document-based investigation evaluation was performed.The evidence indicates the product was made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.No gaps were discovered in the manufacturing instructions, drawing, or quality control procedures for this device.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.An ifu is provided with this device, which states ¿beacon tip catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.Standard techniques for placement if vascular access sheaths, angiographic catheters and wire guides should be employed.¿ the complaint was confirmed based on the journal article.Cook has concluded that no problem with the beacon tip catheter was detected.Per the article, no device malfunction was alleged.The authors believe that the patient¿s stroke was likely caused by unintended migration of the deployed embolization particles.The tumor was located in the pleural space, and the authors believe that the tumor contained an unforeseen shunt, allowing the embolization particles to reach the brain.Due to tortuous anatomy, an approach from the phrenic artery did not result in adequate angiographic visualization.We will continue our monitoring of similar complaints and have 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.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9937680
• MDR Text Key: 187002413
• Report Number: 1820334-2020-00783
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• 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
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 69 YR