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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TRI-LOBE BALLOON CATHETER (ORIGINAL) CATHETER, PERCUTANEOUS

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W.L. GORE & ASSOCIATES AORTIC TRI-LOBE BALLOON CATHETER (ORIGINAL) CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number BCL2645J
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Aneurysm (1708)
Event Date 03/08/2019
Event Type  Injury  
Event Description
On (b)(6) 2019, this patient underwent endovascular treatment for a thoracic aortic aneurysm and a gore® dryseal flex introducer sheath was used to advance and implant a conformable gore® tag® thoracic endoprosthesis. Post deployment the left subclavian artery (lsa) was embolized using plugs. A pacing method was used during the procedure. Prior to device implant a lsa to left common carotid artery (lcca) bypass was performed on the patient. The patient tolerated the procedure with no evidence of endoleak or other complication. On (b)(6) 2019, computed tomography (ct) determined a dissection near the distal end of the endoprosthesis. The physician reported he will monitor the patient and suggests the dissection may have been caused by the increase in blood pressure during pacing; or the touch up ballooning to the distal end of the ctag device.
 
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Brand NameAORTIC TRI-LOBE BALLOON CATHETER (ORIGINAL)
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MEDICAL PHOENIX 1 B/P
32360 n. north valley parkway
phoenix AZ 85085
Manufacturer Contact
laura crawford
1500 n. 4th street
9285263030
MDR Report Key8417787
MDR Text Key138704334
Report Number3007284313-2019-00072
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K033670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 03/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/07/2021
Device Catalogue NumberBCL2645J
Device Lot Number18681022
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/13/2019 Patient Sequence Number: 1
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