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Model Number 5MAXJET7KIT-B
Device Problem Break (1069)
Patient Problems Death (1802); Intracranial Hemorrhage (1891); Device Embedded In Tissue or Plaque (3165)
Event Date 09/04/2019
Event Type  Death  
Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system jet7 kit (kit).During the procedure, the physician advanced the penumbra system jet 7 reperfusion catheter (jet7) over a non-penumbra guidewire up to the m1 occlusion through a neuron max 6f 088 long sheath (neuron max).Next, the physician advanced the jet7 to the clot and turned on aspiration; however, after approximately two minutes, there was no flow of blood in the aspiration tubing.Therefore, the physician started to retract the jet7.Upon reaching the internal carotid artery (ica) terminus, the physician noticed that blood flow started to come through the aspiration tubing and, subsequently, observed that the vessel had recanalized.After removing the jet7, it noticed that the coils at the distal tip of the jet7 were ¿unwound¿ and frayed.The physician then performed a contrast run and noticed a hemorrhage just distal to the ica terminus where the distal tip of the jet7 had broken off and seated.No attempts were made to retrieve the broken tip and the physician ended the procedure at this point.Subsequently, the patient expired; however, the cause of death is unknown at this time.Furthermore, the relationship between the fractured jet7 tip and death is unknown.
Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being reported on this follow-up #03 mfr report: 3005168196-2019-01851.1.Section h.Box 10./11.Narrative/corrected data.Potential adverse events in the labeling with the penumbra system include, but are not limited to, device malfunction, 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.H3 other text : placeholder.
Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #02 mfr report:3005168196-2019-01851.1.Section b.Box 2.Outcomes attributed to adverse event.2.Section h.Box 1.Type of reportable event.3.Section h.Box 6.Evaluation codes (added patient code).H3 other text : placeholder.
Manufacturer Narrative
Please note that the device in complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the hospital kept the device for their evaluation and will not release it to the manufacturer.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text: placeholder.
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Brand Name
Type of Device
Manufacturer (Section D)
one penumbra place
alameda CA 94502
MDR Report Key9151990
MDR Text Key161185471
Report Number3005168196-2019-01851
Device Sequence Number1
Product Code NRY
UDI-Device Identifier00815948020962
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 01/01/2005,09/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/28/2022
Device Model Number5MAXJET7KIT-B
Device Catalogue Number5MAXJET7KIT
Device Lot NumberC16175
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received01/14/2005
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Life Threatening;
Patient Age72 YR