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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 06/26/2017
Event Type  Malfunction  
Event Description

It was reported that the distal markers of the microcatheter were not aligned with the deployment marker of the coil. There were not patient clinical consequences reported due to this event.

 
Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications. The device was returned inside the dispenser hoop. Analysis of the returned device revealed that the catheter shaft was found flat/crushed. The distal tip was found stretched and deformed. The distal tip to proximal ro marker length was measured at 36. 5 mm which is outside of the specification for this product. This deviation was due to the tip being stretched and deformed. In addition, the catheter shaft was found kinked. During functional testing, the catheter was flushed with no difficulties and a test mandrel 0. 0158" was pushed through the lumen with small friction. Based on the investigation results it is confirmed that the reported issue of misalignment of the device marker directly related to the catheter stretch and the deformed distal tip. It is likely that procedural factors contributed to the observed damages to the catheter limiting the performance of the device during the clinical procedure. Therefore, an assignable cause of operational context has been assigned to this investigation.

 
Event Description

It was reported that the distal markers of the microcatheter were not aligned with the deployment marker of the coil. There were not patient clinical consequences reported due to this event.

 
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Brand NameEXCELSIOR SL-10 150CM 2 TIP
Type of DeviceCATHETER, 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 Key6734338
MDR Text Key80761483
Report Number3008881809-2017-00219
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeAR
PMA/PMN NumberK013789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2019
Device Catalogue NumberM0031681890
Device LOT Number19643594
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/06/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/07/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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