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

Catalog Number	CID-20-30
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, during an unspecified procedure, the stopcock of the sphere inflation device would not attach to the cook balloon.The stopcock would not seal correctly.It kept spinning as if it were stripped.The physician removed the stopcock and proceeded with no further issues.No patient harm was reported and no additional procedures were required.
Additional Manufacturer Narrative
Type of reportable event: not reportable.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 7865529
• Report Number: 1820334-2018-02646
• Device Sequence Number: 16647399
• Product Code: MAV
• UDI-Device Identifier: 10827002310275
• UDI-Public: (01)10827002310275(17)210331(10)96271391
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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 Expiration Date: 03/31/2021
• Device Catalogue Number: CID-20-30
• Device Lot Number: 96271391
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1