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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC UNKNOWN ENVOY 6F PERCUTANEOUS CATHETER

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CODMAN AND SHURTLEFF, INC UNKNOWN ENVOY 6F PERCUTANEOUS CATHETER Back to Search Results
Catalog Number 6702XXXX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Muscle Spasm(s) (1966)
Event Date 12/01/2015
Event Type  Injury  
Manufacturer Narrative

Fawaz all-mufti et al (2016). Pipeline embolization device deployment via an envoy distal access xb guiding catheter¿biaxial platform: a technical note, interventional neuroradiology 2016, vol. 22(2) 236¿239, doi: 10. 1177/1591019915623558. Since lot number was not available, the lot and expiration dates of the device could be provided. Three attempts to obtain additional information were unsuccessful. The date of the event was unknown. Conclusion: the device was not available for analysis. In addition, the lot number was not provided; therefore, a dhr review could not be performed. Vasospasm is a known procedural event associated with the device and with advancing devices through cerebral arteries. Based on the information provided in the article, patient anatomy (small vessel diameter) may have contributed to the event. There was no evidence of a manufacturing issue; therefore, no corrective actions will be taken at this time. This is an initial/final mdr report.

 
Event Description

In the literature article ¿pipeline embolization device deployment via an envoy distal access xb guiding catheter¿biaxial platform: a technical note¿ by fawaz al-mufti, krishna amuluru, inder paul singh, chirag gandhi and charles j prestigiacomo, published interventional neuroradiology 2016, vol. 22(2) 236¿239, doi: 10. 1177/1591019915623558, it was reported that an unknown envoy mpd guide catheter (catalog/lot unknown) caused cerebral vasospasm during an interventional procedure. The patient had presented with headache and was diagnosed with multiple unruptured intracranial aneurysms and was admitted for treatment. Per the article: ¿because of the patient¿s anatomy, the parent vessel diameter could not safely accommodate anything greater than a 6 french guide catheter. On the initial flow-diversion access attempt, a 6 french envoy mpd 0. 070-inch inner diameter (id), 100 cm guide catheter was used to access the internal carotid artery (ica). However, the catheter was unable to track distally to cervical tortuosity and severe catheter-induced vasospasm resulted. Hence the catheter was removed and intra-arterial verapamil was administered with resolution of spasm. ¿ an envoy da device was then safely navigated across the cervical tortuosity and tracked distally to the horizontal segment of the petrous ica without spasm. The patient tolerated the procedure well and was discharged in stable condition the following day. No additional information could be obtained.

 
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Brand NameUNKNOWN ENVOY 6F
Type of DevicePERCUTANEOUS CATHETER
Manufacturer (Section D)
CODMAN AND SHURTLEFF, INC
325 paramount dr
raynham MA
Manufacturer Contact
karen anigbo
circuito interior norte #1820
juarez chihuahua 32580
MX   32580
5088288374
MDR Report Key6356492
MDR Text Key68271618
Report Number3008264254-2017-00019
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK093184
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 01/31/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6702XXXX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/24/2017 Patient Sequence Number: 1
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