MAUDE Adverse Event Report: COOK INC SPHERE INFLATION DEVICE

Catalog Number	CID-20-30-NG
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2018
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, the sphere inflation device leaked during a balloon artery dilatation procedure.It was initially reported that a mixture of blood and contrast began leaking from the "plunger" of the device during inflation of another manufacturer's balloon catheter, but later clarified that "there was no amount of blood loss, just some leaking through the syringe/barrel." another sphere inflation device was opened and used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Additional information: type of reportable event.Type of reportable event: not reportable.This incident was previously reported to capture the initially reported failure mode.However, following a cross functional assessment of the risks posed by this failure mode, it was determined that the risk to the patient is not substantial enough to warrant reporting under 21 cfr part 803 reporting regulations.As such, this incident has been reassessed and is no longer reportable.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 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
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7774239
• Report Number: 1820334-2018-02418
• Device Sequence Number: 2433888
• Product Code: MAV
• UDI-Device Identifier: 10827002255712
• UDI-Public: (01)10827002255712(17)210228(10)96469016
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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: 02/28/2021
• Device Catalogue Number: CID-20-30-NG
• Device Lot Number: 96469016
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1