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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC

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COOK INC Back to Search Results
Device Problem Peeled/Delaminated (1454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Common name & product code
unavailable as the device lot number, rpn, and gpn are unknown. Pma/510(k) number
unavailable as the device lot number, rpn, and gpn are unknown. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
Event Description
It was reported, the cook balloon catheter (product and lot number is not known) splintered during a tibial artery percutaneous transluminal angioplasty (pta). Per the physician, there was no problem activating the device's hydrophilic coating; it was not tacky. It is unclear if a competitor's balloon catheter was used to complete the procedure or if the issue was noted after the completion of the procedure. There was no adverse patient effect. It was further reported the device is not available for return to the manufacturer for investigation.
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Manufacturer (Section D)
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
MDR Report Key7759643
MDR Text Key116869047
Report Number1820334-2018-02319
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial