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	06/27/2018
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 tighten.At the time of the event, a balloon angioplasty was being performed; however, the complaint device never made patient contact.The complainant reported this event did not negatively affect the procedure.It was completed without any adverse effects to the patient.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, drawing, quality control, specifications, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual and functional inspections of the returned device following inflation were unremarkable.The male and female luers on the returned stopcock passed the general luer fitting test, and the functional capabilities of the device were determined to be satisfactory when normal usage conditions were simulated.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record for the complaint lot indicated that the devices were manufactured under normal operating procedures.There were two other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• 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: 7713956
• Report Number: 1820334-2018-02299
• Device Sequence Number: 995685
• Product Code: MAV
• UDI-Device Identifier: 10827002310275
• UDI-Public: (01)10827002310275(17)210331(10)96271390
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER; BALLOON CATHETER