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

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.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9151990
• MDR Text Key: 161185471
• Report Number: 3005168196-2019-01851
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: 00815948020962
• Combination Product (y/n): Y
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2022
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: C16175
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 01/13/2020; 01/14/2005; 01/14/2005
• Supplement Dates FDA Received: 01/16/2020; 06/04/2020; 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 72 YR