MAUDE Adverse Event Report: COOK INC

Device Problem Flaked (1246)

Patient Problems Death (1802); Myocardial Infarction (1969); Foreign Body In Patient (2687)

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.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.Klys, h.S., salmon, a.P., & giovanni, j.V.(1991).Paradoxical embolisation of a catheter fragment to a coronary artery in an infant with congenital heart disease.Heart, 66(4), 320-321.Doi: 10.1136/hrt.66.4.320,.

Event Description

It was reported, an infant died 6 weeks after a cardiac catheterization.A mullins sheath (reference mdr 1820334-2018-03008) and a park blade (reference this report) were two of the devices used during the catheterization.A 1991 journal article titled, ¿paradoxical embolization of a catheter fragment to a coronary artery in an infant with congenital heart disease¿ was reviewed.The article discussed the finding, during necropsy, of a thrombus containing bismuth in the circumflex coronary artery.The authors suggest that the bismuth-containing material was derived from a catheter used during cardiac catheterization.According to the authors, a six-week-old male infant presented to the hospital with a three-week history of poor feeding and failure to thrive.The infant was cyanosed and in heart failure.A diagnosis of complete transposition of the great arteries and a large perimembranous ventricular septal defect was made and the patient underwent a cardiac catheterization procedure.During the procedure, a small, patent foramen ovale was found but could not be crossed with a septostomy catheter (manufacturer not stated).A guide wire (manufacturer not stated) was passed across the foramen ovale making it possible to cross the septum with a mullins sheath.A blade septostomy was performed with a park blade which was followed by a balloon (manufacturer not stated) atrial septostomy.Left atrial pressure fell and right atrial oxygen saturation rose.The aorta was not entered.The patient remained stable throughout the procedure.The following day, the patient developed a fever.Echocardiography showed an adequate septostomy but left ventricular function was impaired.A clinical diagnosis of sepsis was made, and the patient was treated with antibiotics with good effect resulting in discharge from the hospital after one week.Three weeks later the patient was admitted with a febrile illness associated with lymphocytosis.Viral studies were negative, and the fever resolved over the next three weeks.Repeat echocardiogram showed left ventricular size and fractional shortening had returned to normal.Six-weeks after cardiac catheterization the patient underwent an arterial switch repair with closure of the ventricular septal defect.The operation was technically successful, but it was impossible to discontinue cardiopulmonary bypass because of severe left ventricular dysfunction.The patient expired.At necropsy, the transposition of the great vessels was seen along with the transmural fibrous scar in the apical portion of the posterior wall.Examination of the circumflex artery under dissecting microscope showed a 1.5-centimeter (cm) length was occluded.Histological examination of the posterior wall of the left ventricle confirmed an infarct that was several weeks old.There was no evidence of myocarditis.Organized thrombus with partial recanalization was found within the circumflex artery.Higher power magnification showed giant cells containing refractile foreign material within the thrombus.This material was analyzed by electron probe x ray.Analysis by energy dispersive x ray showed the presence of both iron and bismuth.The authors noted, in retrospect, the patient had become unwell after the cardiac catheterization procedure and, it became clear, had sustained a myocardial infarction during the procedure.With transposition of the great vessels ventricular preload is increased and afterload is reduced.The apparent return to normal left ventricular function was misleading and the increase in afterload that occurred after anatomical correction resulted in intractable cardiac failure.According to the article, electron probe x ray analysis was found to have the ability to relate chemical composition to tissue morphology.The refractile material found in the lumen of the occluded circumflex coronary artery contained bismuth salts which, the authors state, are used to make catheters radio-opaque.The authors concluded, the pathological findings and clinical history provide conclusive evidence that coronary artery thrombosis occurred at the time of cardiac catheterization.No damage to the catheters was noted during the procedure.The authors assumed the fragment arose from within the lumen.It was noted particles are released when cardiac catheters are flushed and the increased risk after one insertion of a guide wire.Additionally, it was stated, evidence suggests an increased risk of fragment separation from re-used catheters.In this event, several guide wire insertions were performed.According to the authors, the extensive use of guide wires in interventional catheterizations highlights the need for improved catheter technology.Upon follow up with the one of the journal authors, it was reported neither device identifiers nor complaint sample are available.The physician additionally reported, as far as he can recall, the death was not related to the equipment.

Manufacturer Narrative

Investigation - evaluation : a review of the complaint history, documentation, manufactures instructions, 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.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Additionally, a documentation review was attempted.However, the journal article did not provide a catalog or lot number for the park blade septostomy catheter.Cook inc.Manufactures three versions of the device.All three models were available prior to 1991 and could have been used for the blade septostomy procedure.It cannot be confirm which model was used with the information provided in the journal article.Current quality control and manufacturing documentation was reviewed.A review of the imaging noted a thromboembolism containing bismuth particles was confirmed, but the thromboembolism was not produced by the particles.The thromboembolism just contained bismuth particles.The particles were far too small too occlude the circumflex coronary artery.The particles only signified that the thromboembolism came from inside a catheter.The event of particle liberation from a certain catheter or by a certain device cannot be confirmed.¿ moreover, based on current information from the journal article and the imaging reviewer there is no evidence to suggest a relationship between either of the cook devices and the particles discovered in the thromboembolism.There is also no relationship between the patient¿s death and the cook manufactured devices.There is no evidence to suggest the catheters or sheath malfunctioned and the article states, ¿no damage to the catheters was noted during the procedure.¿ we have no information about the wire guide and there is no rpn or lot number regarding the mullins sheath or the park blade catheter.There are assumptions made in the article regarding the origin of the iron and bismuth fragments.Furthermore, the patient cause of death was not specifically stated but only that following a successful "arterial switch repair with closure of the ventricular septal defect, it was impossible to discontinue cardiopulmonary bypass because of severe left ventricular dysfunction.The patient died.¿ there is no death certificate or autopsy report.The origin of the particles is not known and the article assumes ¿that the fragment arose from within the lumen.¿ at this time, the most probable cause of the patient¿s death is disease progression related based on the information provided, no product returned and the results of our investigation, a definitive problem with the device could not be detected.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.

Event Description

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

• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7938305
• MDR Text Key: 122840018
• Report Number: 1820334-2018-03009
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2018
• 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: MULLIN SHEATH, UNKNOWN GUIDE WIRES
• Patient Outcome(s): Death
• Patient Age: 3 MO