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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 150CM 2 TIP; CATHETER, PERCUTANEOUS
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STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 150CM 2 TIP; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number M0031681890
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2018
Event Type  malfunction  
Event Description
It was reported that during the embolization procedure while advancing the subject microcatheter into the blood vessel, the distal marker in the radiographic image was not visible.There were no clinical consequences reported to the patient.
 
Manufacturer Narrative
Product available to stryker and returned date: updated.Device evaluated by mfg and summary attached: updated.The device history record review confirms that the device met all material, assembly and performance specifications.Product analysis of the returned device confirmed both (radio opaque) ro markers were visible under x-ray and the proximal and distal ro marker diameter was measured and were within specification.The complaint for ro markers were not visible during the clinical procedure was not confirmed.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
 
Event Description
It was reported that during the embolization procedure while advancing the subject microcatheter into the blood vessel, the distal marker in the radiographic image was not visible.There were no clinical consequences reported to the patient.
 
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Brand Name
EXCELSIOR SL-10 150CM 2 TIP
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key7284067
MDR Text Key100577713
Report Number3008881809-2018-00081
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K013789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2019
Device Catalogue NumberM0031681890
Device Lot Number20155800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age60 YR
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