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

Catalog Number	CID-20-30
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2018
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 stop cock of the sphere inflation device would not properly connect during a percutaneous transluminal angioplasty procedure.Initial access was gained through the left radial vein to the cephalic vein.The physician attempted to connect the stop cock of the sphere inflation device to an angioplasty balloon device, but it was unsuccessful.Therefore, another manufacture's device was used instead.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: h1.H1: 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
• Common Device Name: MAV SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7812840
• Report Number: 1820334-2018-02452
• Device Sequence Number: 2547877
• Product Code: MAV
• UDI-Device Identifier: 10827002310275
• UDI-Public: (01)10827002310275(17)210331(10)96271390
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K953522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• 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: 03/31/2021
• Device Catalogue Number: CID-20-30
• Device Lot Number: 96271390
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 08/24/2018
• 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