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

Model Number	5MAXJETDKIT-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vasoconstriction (2126); Vomiting (2144)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Additional 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, vessel spasm, inability to completely remove thrombus, hematoma or hemorrhage at access site, intracranial hemorrhage, ischemia, including death.Therefore, it was determined that the reported adverse events were anticipated complications.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Additional 510(k)# that also applies to this complaint: k133317.
Event or Problem Description
On (b)(6) 2019, the patient underwent a thrombectomy procedure in the m2 segment of the middle cerebral artery (mca) using a penumbra system jetd reperfusion catheter (jetd), penumbra system 3max reperfusion catheter (3maxc), and neuron max 6f 088 long sheath (neuron max).During the procedure, the physician placed the 3maxc, jetd, and neuron max in the target vessel and used the jetd to perform aspiration.A follow-up angiogram showed recanalization of over 50% of the occluded branch.However, minimal catheter-induced vasospasm was present.It was not treated as the patient showed continued improvement.The physician then attempted to catheterize the occluded branch, but the patient began to experience emesis; therefore, the devices were removed.The two events were considered resolved on the same day.The procedure ended at this point, and a thrombolysis in cerebral infarction (tici) grade 2b recanalization was achieved.The vasospasm was reported to be a non-serious adverse event with a definite relationship to the index procedure and jetd, and the emesis was reported to be a non-serious adverse event with a probable relationship to the index procedure and jetd.

• Brand Name: PENUMBRA SYSTEM JETD REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9712471
• Report Number: 3005168196-2020-00178
• Device Sequence Number: 11363024
• Product Code: NRY
• UDI-Device Identifier: 00814548019741
• UDI-Public: 00814548019741
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K090752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 5MAXJETDKIT-A
• Device Catalogue Number: 5MAXJETDKIT
• Device Lot Number: F88770
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Date Report Sent to FDA: 01/01/2005