MAUDE Adverse Event Report: COOK INC SPHERE INFLATION DEVICE; MAV SYRINGE, BALLOON INFLATION

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dept.Interventional radiology.Event is still under investigation at this time.
Event or Problem Description
Information was provided that a piece of metal was noted to be in the chamber of the device where the saline goes in.This had not been introduced in the patient; however, it was on the table with the patient.Another of the same device was used to complete the procedure.
Additional Manufacturer Narrative
(b)(6).Evaluation: during the investigation, it was determined that cook inc.Is not the labeled manufacturer for the sphere inflation device.The manufacturer has been notified of this event.
Event or Problem Description
Information was provided that a piece of metal was noted to be in the chamber of the device where the saline goes in.This had not been introduced in the patient; however, it was on the table with the patient.Another of the same device was used to complete the procedure.

• Brand Name: SPHERE INFLATION DEVICE
• Common Device Name: MAV SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6167381
• Report Number: 1820334-2016-01481
• Device Sequence Number: 929775
• Product Code: MAV
• UDI-Device Identifier: 10827002255712
• UDI-Public: (01)10827002255712(17)190531(10)96469003
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K953522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CID-20-30-NG
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2016
• Supplement Report FDA Received Date: 01/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1