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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAPID MEDICAL LTD. COMANECI 17
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RAPID MEDICAL LTD. COMANECI 17 Back to Search Results
Model Number ANPP7199
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Aneurysm (1708)
Event Date 03/10/2023
Event Type  Injury  
Event Description
Comaneci 17 was deployed across the neck of the basilar aneurysm.5 target coils were detached.Upon detachment of the final coil, it was discovered a coil was entangled within the mesh of the comaneci 17.The physician reduced and expanded comaneci 17 but was unable to separate the coil from the comaneci 17.The physician ultimately advanced his benchmark to the comaneci 17 and pulled it along with the coil out of the body.A loop of another coil was then in the pca and basilar.The physician deployed two atlas stents to tack down the coil loops and then the procedure ended.
 
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Brand Name
COMANECI 17
Type of Device
COMANECI 17
Manufacturer (Section D)
RAPID MEDICAL LTD.
po box 337
carmel building
yokneam, israel 20692 05
IS  2069205
MDR Report Key16618079
MDR Text Key312023398
Report Number3015531723-2023-00005
Device Sequence Number1
Product Code PUU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 03/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberANPP7199
Device Catalogue NumberANPP7199
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/27/2023
Distributor Facility Aware Date03/27/2023
Event Location Hospital
Date Report to Manufacturer03/27/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age61 YR
Patient SexFemale
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