MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER; NRY

Model Number 5MAXJET7KIT-B

Device Problems Break (1069); Stretched (1601)

Patient Problems Death (1802); Extravasation (1842); Vascular Dissection (3160)

Event Date 05/26/2020

Event Type  Death  

Manufacturer Narrative

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, vessel spasm, thrombosis, dissection, or perforation, ischemia, including death.Therefore, it was determined that the reported adverse events were anticipated complications.Please note that this complaint was submitted to the fda by the user facility with the following reference number:mw5095612 the product lot number was not provided, therefore, the manufacturing records could not be reviewed.(b)(4).

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), velocity delivery microcatheter (velocity), non-penumbra stent retriever, guide catheter, and groin sheath.It was reported that the patient had an ischemic stroke in the m1 segment of the right mca and a nih stroke scale/score (nihss) of 23 on arrival.During the procedure, the physician completed two passes in the target vessel using the jet7 and velocity and another two passes using the jet7 and velocity with the stent retriever.Subsequently, the jet7 and stent retriever were removed.An angiographic run was performed through the guide catheter and residual clot was visualized in the anterior cerebral artery (aca).An attempt was made to re-advance the jet7 with the velocity to the face of the clot, but difficulty was experienced.The velocity was removed.Contrast was injected through the jet7 to perform another angiographic run.The tip of the jet7 expanded and broke, which was hanging by the coil wind.The vessel in the internal carotid artery (ica) ruptured; extravasation and a subarachnoid hemorrhage (sah) were observed.To stop the bleeding, a balloon catheter was immediately advanced to the ica.However, the broken tip of the jet7 was occluded and did not allow the balloon catheter access to the ruptured vessel.Subsequently, the physician decided to remove the jet7.As the jet7 was pulled to remove it, the tip became stuck in the guide catheter.Attempts were made to remove the jet7 without removing the guide catheter but were unsuccessful.The jet7 and guide catheter were then pulled together, and the tip of became stuck in the groin sheath.Therefore, the entire system was removed.To re-access the ica, another guide sheath and the balloon catheter were advanced to the ruptured vessel.The follow-up angiographic run showed complete occlusion of the ica from the cavernous segment, most likely from dissection.A computed tomography (ct) scan of the head revealed diffuse sah.An external ventricular drain (evd) was placed in the patient.However, the patient continued to show poor neurological examination.Due to poor prognosis, care was withdrawn after 48 hours, and the patient expired.

• Brand Name: PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 10440334
• MDR Text Key: 203973409
• Report Number: 3005168196-2020-01255
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: 00815948020962
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K190010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 61 YR