MAUDE Adverse Event Report: ETHICON INC. BLAKE DRAIN UNKNOWN PRODUCT; CATHETER, IRRIGATION

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Ischemia (1942); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Citation: the heart surgery forum #2010-1112 14 (3), 2011; doi: 10.1532/hsf98.20101112.

Event Description

Literature article: an uncommon cause of myocardial ischemia after coronary artery bypass grafting: ¿the dangerous drainage¿.The authors presented patient with chief complaint of chest pain.The patient had a history of coronary artery bypass graft.The patient underwent cardiac catheterization which showed significant stenosis bypass to the right marginal artery and the native right coronary artery (rca).Coronary surgery where a venous bypass to the rca was performed.The patient showed signs of myocardial ischemia on serial electrocardiograms and supported with lab analyses of increased creatine kinase and troponin i.A postoperative cardiac catheterization was performed which showed that the silicon drain was putting pressure on the bypass, thereby impeding blood flow through the venous graft.The drain was immediately removed, and the bypass recovered its functionality.The author stated that myocardial ischemia and/or infarction occurring after cabg should prompt consideration of the possibility of mechanical compromise of a bypass graft by a drainage tube, even when soft silicone drains are used.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 9/14/2020.

• Brand Name: BLAKE DRAIN UNKNOWN PRODUCT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7291064
• MDR Text Key: 100755764
• Report Number: 2210968-2018-71000
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR