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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER NRY

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PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER NRY Back to Search Results
Model Number 5MAXJET7KIT-B
Device Problem Material Deformation (2976)
Patient Problems Death (1802); Fistula (1862); Vascular Dissection (3160)
Event Date 04/24/2020
Event Type  Death  
Manufacturer Narrative

Potential adverse events in the labeling with the penumbra system include, but are not limited to, arteriovenous fistula, vessel spasms, thrombosis, dissection, or perforation, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, ischemia, including death. Therefore, it was determined that the reported adverse events were anticipated complications. Results: the returned jet7 was fractured approximately 129. 0 cm from the hub. Conclusions: evaluation of the returned jet7 confirmed a distal fracture. This damage typically occurs due to forceful retraction against resistance. Based on the reported event, there were no retrieval attempts for the fractured tip of jet7. This indicates the device did not completely fracture until removed from the patient body. If the catheter was stretched or otherwise damaged, it may worsen to a fracture after additional manipulation. The root cause of the initial damage could not be determined. The distal tip of the non-penumbra sheath was ovalized. A demonstration jet7 was able to be advanced through the returned non-penumbra sheath without issue. Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

 
Event Description

The patient was undergoing a thrombectomy procedure in the right m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), non-penumbra stent retriever, non-penumbra microcatheter, and non-penumbra sheaths. It was reported that the patient had covid-19 and left-sided weakness with facial droop. During the procedure, the physician completed two passes in the target vessel using the jet7 with the stent retriever. The physician withdrew the stent retriever without significant resistance on both passes. The passes resulted in a thrombolysis in cerebral infarction (tici) grade 2b. A contrast run was then performed and showed a tear and a carotid-cavernous fistula (ccf) had formed. Subsequently, the physician decided to remove the jet7. Upon removal, it was noticed that the distal end of the jet7 was fractured. The procedure ended at this point. The patient had pneumonia from covid-19, left paralysis and was intubated. One day post-procedure, the patient was comatose with glasgow coma scale (gcs) 3. The patient later expired due to complications of the stroke and intracranial pressure (icp).

 
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Brand NamePENUMBRA SYSTEM JET7 REPERFUSION CATHETER
Type of DeviceNRY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key10063449
MDR Text Key191233487
Report Number3005168196-2020-00657
Device Sequence Number1
Product Code NRY
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK190010
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 01/01/2005,04/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2020
Is This An Adverse Event Report? Yes
Device Operator NO INFORMATION
Device MODEL Number5MAXJET7KIT-B
Device Catalogue Number5MAXJET7KIT
Device LOT NumberF94509
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/29/2020
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 Received04/24/2020
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 05/15/2020 Patient Sequence Number: 1
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