MAUDE Adverse Event Report: COOK, INC. COOK NESTER COIL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Ct scan performed on (b)(6) 2020 shows metallic foreign body/coil within the right ventricle.Foreign body extension into the myocardium although the majority of this foreign body appears within the lumen of the right ventricle.Fda safety report id # (b)(4).

• Brand Name: COOK NESTER COIL
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• MDR Report Key: 11435109
• MDR Text Key: 238685231
• Report Number: MW5099821
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2021

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: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 122