MAUDE Adverse Event Report: COOK INC UNKNOWN

Model Number N/A

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Common name: unknown.Rpn and lot information were not provided in the source article.Product code: unknown.Rpn and lot information were not provided in the source article.Pma/510(k) #: 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 to customer relations: "a (b)(6) male presented with a 2-year history of canadian class 3 angina, refractory to medical therapy.He had a background history of an ischemic cardiomyopathy, having sustained two previous myocardial infarctions and had undergone surgical revascularization twice previously (last operation 21 years prior).He had a primary prevention implantable cardioverter defibrillator in situ.His comorbidities included paroxysmal atrial fibrillation, hypertension, and dyslipidemia.Renal function was preserved.Echocardiography revealed moderate left ventricle (lv) systolic dysfunction with an akinetic apex and hypokinetic inferior wall.A nuclear scan confirmed viability in the inferior wall.Coronary angiography demonstrated occluded proximal native vessels with occluded vein grafts to the left circumflex (lcx) and right coronary arteries with a patent left internal mammary to left anterior descending artery.Pci to the lcx cto then pci to the right coronary artery (rca) cto was planned.Pci to the lcx cto was successful using an antegrade dissection re-entry strategy (crossboss catheter and stingray wire/balloon for controlled re-entry, st jude medical, st paul, mn) and an excellent angiographic result was achieved after implantation of three overlapping drug eluting stents (fig.1; supporting information videos 1 and 2).Pci to the rca was undertaken in the same sitting as a primary retrograde strategy via epicardial collaterals from the lcx (fig.2).The collaterals were crossed with a sion wire (asahi intec, aichi, japan) supported by a corsair catheter (asahi intec, aichi, japan).The procedure was completed by retrograde dissection reentry, wire externalization and deployment of five overlapping drug eluting stents.A small perforation in the small, tortuous epicardial collateral was evident on withdrawal of the retrograde equipment (fig.3; supporting information videos 3 and 4).As the perforation appeared small and contained, no immediate intervention was performed.Thirty minutes after the completion of the procedure, the patient became hypotensive requiring inotropic support.Urgent echocardiography revealed a small, retrocardiac collection that was causing left atrial compression and compromising ventricular filling (fig.4), while urgent computed tomography scan (ct) showed a large retrocardiac, intrapericardial hematoma causing significant left atrial compression (supporting information videos 5 and 6).Urgent ct guided percutaneous drainage of the hematoma was performed by the interventional radiology team.Using a right lateral thoracic approach, a 20-gauge needle (20-cm long) was advanced through the right lung into the intrapericardial hematoma.An 0.018-in.Diameter nitinol guide wire was advanced through the needle, over which a 5 french coaxial introducer (merit medical, south jordan, ut) was delivered into the hematoma.A rosen wire (cook medical, bloomington, in) was introduced through this that afforded delivery of a 12 french pigtail drainage catheter (cook medical).The hematoma was evacuated and the blood pressure immediately improved.(figs.5 and 6).The procedure was complicated by a right hemothorax, which required percutaneous drainage.An excellent recovery was made and the patient discharged 5 days later.He remained well and free of angina at 6-month follow up.This report # was created to detail the involvement of the unknown cook 12 french pigtail drainage catheter mentioned in the source article.Mdr #1820334-2019-00788 was created to detail the involvement of the cook rosen wire mentioned in the source article.

Manufacturer Narrative

Investigation ¿ evaluation.A review of the complaint history, drawing, manufacturing instructions, and quality control of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.There have been no other reported complaints for similar devices with the same/similar failure modes to use as a reference failure analysis.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Cook could not review the dhr for the complaint device based on the lack of information within the journal article.A report could not be reviewed to narrow down potential lots effectively because both the rpn and lot number are unknown.Based on the known information, there is no evidence to suggest there is nonconforming product in house or out in the field.Based on the information provided, no returned product and the results of the investigation, a definitive cause could not be established.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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 regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8482466
• MDR Text Key: 141033952
• Report Number: 1820334-2019-00789
• Device Sequence Number: 1
• Product Code: EYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 05/09/2019
• Supplement Dates FDA Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR