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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 on the sphere inflation device would not lock/attach to the cook 35 lp balloon.This device does not make patient contact.The right lower leg angioplasty procedure was successfully completed using another inflation device.According to the complainant, the patient did not experience any adverse effects as a result of this occurrence.
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, trends, and a visual inspection and functional evaluation of the returned device were conducted during the supplier investigation.The device passed all functional testing in both test iterations and remained securely connected throughout all testing.The visual inspection revealed no anomalies.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.Based on the information provided, the examination of the returned product, and the results of the supplier investigation, the root cause was traced to the user.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 7722083
• Report Number: 1820334-2018-02300
• Device Sequence Number: 1409637
• Product Code: MAV
• UDI-Device Identifier: 10827002310275
• UDI-Public: (01)10827002310275(17)210331(10)96271389
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

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: 96271389
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 10/31/2018
• 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: COOK 35 LP BALLOON