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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED ADVANCE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COOK INCORPORATED ADVANCE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number G50315
Device Problems Material Separation (1562); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/23/2020
Event Type  malfunction  
Event Description
Doctor reports that when he visually inspected the balloon before using, he noted there was separation where the balloon meets the shaft, which meant that it was defective and would not inflate. He did not put the balloon in the body. He recognized that it was defective first.
 
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Brand NameADVANCE
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key10918867
MDR Text Key218685038
Report Number10918867
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG50315
Device Catalogue NumberPTAX4-14-170-2-6
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/11/2020
Event Location No Information
Date Report to Manufacturer11/30/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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