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

Catalog Number 5MAXJET7KIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 04/14/2021

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the penumbra system include, but are not limited to, dissection, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, vessel spasm, thrombosis, ischemia, including death.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

The patient was undergoing a thrombectomy procedure in the m1 and m2 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), penumbra system 5max reperfusion catheter (5maxc), and penumbra system 3max reperfusion catheter (3maxc).During the procedure, the physician made multiple passes with the 5maxc to clear the m2.The physician was using the jet7 to clear the m1; however, when a contrast injection run was performed, a dissection was noted in the carotid.No additional information regarding the completion of the procedure was provided.It was reported the patient had one sided paralysis and is in rehab.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:.1.Section h.Box 1.Type of reportable event 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 11821994
• MDR Text Key: 251200277
• Report Number: 3005168196-2021-01033
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K173761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/05/2022

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?: No
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Male