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

Catalog Number	5MAXJETDKIT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Intracranial Hemorrhage (1891)
Date of Event	10/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional 510(k) # that also apply to this complaint: k133317.The product was not returned for evaluation.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.This report is associated with mfr report number: 3005168196-2019-00648.
Event or Problem Description
The patient underwent a thrombectomy procedure in the middle cerebral artery using a penumbra system jetd reperfusion catheter (jetd) and a penumbra system 3max reperfusion catheter (3maxc) on (b)(6) 2018.On (b)(6) 2018, the patient experienced an asymptomatic hi-1 small petechial hemorrhage in the left insula.This event was not considered a serious adverse event.This event was adjudicated to be related to penumbra catheters, possibly related to the jetd and a 3maxc, and possibly related to the index procedure.No additional treatment was done, and this event was considered resolved as of (b)(6) 2018.
Additional Manufacturer Narrative
Please note that the following sections were not referenced on the initial mfr report and are being addressed on this follow-up #01 mfr report: 3005168196-2019-00647 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, 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.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2019-00648.

• 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: 8489366
• Report Number: 3005168196-2019-00647
• Device Sequence Number: 11237791
• Product Code: NRY
• UDI-Device Identifier: 00814548019741
• UDI-Public: 00814548019741
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 03/07/2019
• 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: 03/12/2021
• Device Catalogue Number: 5MAXJETDKIT
• Device Lot Number: F82291
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/16/2019
• 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: Hospitalization
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005