MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Model Number	3MAXCKIT-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 and m2 segment of the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc).During the procedure, the physician advanced a 3maxc through a penumbra system jetd reperfusion catheter (jetd) to the target vessel.Upon removal of the 3maxc and jetd after an unsuccessful pass, it was noticed that the marker band of the 3maxc remained in the m1 segment.The physician then made 2-3 attempts to retrieve the broken 3maxc tip using a stent retriever; however, the attempts were unsuccessful.The marker band of the 3maxc remained in the patient and the procedure was aborted.On (b)(6) 2019, it was reported that the patient had expired; however, the cause of death is unknown at this time.Furthermore, the relationship of the 3maxc to the patient''s death is unknown.
Additional Manufacturer Narrative
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 event was an anticipated complication.Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was retained by the hospital and is not available for return.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.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9447729
• Report Number: 3005168196-2019-02270
• Device Sequence Number: 11370542
• Product Code: NRY
• UDI-Device Identifier: 00814548019949
• UDI-Public: 00814548019949
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• 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): 11/12/2019
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2022
• Device Model Number: 3MAXCKIT-A
• Device Catalogue Number: 3MAXCKIT
• Device Lot Number: F91132
• 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: 11/12/2019
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 04/02/2020
• 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: Required Intervention
• Patient Age: 46 YR
• Date Report Sent to FDA: 01/01/2005