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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 SHEATH DQY

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PENUMBRA, INC. NEURON MAX 6F 088 SHEATH DQY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Spasm(s) (1966); Injury (2348)
Event Date 12/13/2018
Event Type  Injury  
Manufacturer Narrative

Vasospasm is a known and anticipated complication with these types of procedures and are noted in the device labeling. Therefore, it was determined that the reported event was an anticipated procedural complication. The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined. This report is associated with mfr report numbers: 1. 3005168196-2019-00079, 2. 3005168196-2019-00080, 3. 3005168196-2019-00081, 4. 3005168196-2019-00082, 5. 3005168196-2019-00088.

 
Event Description

The patient was undergoing a thrombectomy procedure in the basilar artery using penumbra system 3max reperfusion catheters (3maxcs), a penumbra system jetd reperfusion catheter (jetd), a velocity delivery microcatheter (velocity), penumbra system 3d revascularization device (3d) and a neuron max 6f 088 long sheath (neuron max). It should be noted that the patient¿s anatomy was tortuous, and the physician decided to take a radial approach. During preparation for the procedure, the first 3maxc became bent on the back table and was not used in the procedure. A second 3maxc was then advanced through a neuron max followed by a 3d; however, the 3d was unable to advance through the 3maxc beyond the v3 segment. Therefore, the 3d and the 3maxc were removed from the vessel and set aside. The physician then advanced the velocity through a jetd into the basilar artery using the same neuron max; however, the velocity was unable to advance to the target location. The velocity and jetd were therefore removed from the patient¿s vessel. During the next angiogram, the physician identified a radiopaque marker inside the patient¿s mid basilar artery. It was then noted that the second 3maxc used had fractured and remained in the patients vessel. The physician then attempted to advance a guidewire to the basilar artery to continue the procedure but was unable to advance it further. The guidewire was therefore removed. The physician then decided to end the procedure. However, the physician experienced difficultly removing the neuron max as the patient began having vasospasms. Upon removal of the neuron max, the procedure ended and the basilar artery remained occluded. It was reported that the patient passed away a few days later on (b)(6) 2018. It was also reported that the cause of death was respiratory arrest; however, the relationship between the fractured 3maxc tip and the cause of death is currently unknown.

 
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Brand NameNEURON MAX 6F 088 SHEATH
Type of DeviceDQY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key8242973
MDR Text Key132910150
Report Number3005168196-2019-00083
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK111380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,12/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received12/14/2018
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 01/12/2019 Patient Sequence Number: 1
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