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

Model Number	5MAXJETDKIT
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510(k)# that also applies to this complaint: (b)(4).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 segment of the segment of the middle cerebral artery (mca) and the internal carotid artery (ica) using a neuron max 6f 088 long sheath (neuron max), a penumbra system jet 7 reperfusion catheter (jet7), and a penumbra system jetd reperfusion catheter (jetd).During the procedure, the physician used a neuron max and jet7 to remove thrombus in the ica.Then, due to patient¿s anatomy and vessel dimensions, the physician removed the jet7 and it was no longer used for the remainder of the procedure.Afterwards, the physician advanced a jetd through the neuron max to remove thrombus in the m1 segment of the mca.The physician then completed three passes and while removing the jetd, the physician experienced resistance.Subsequently, the distal end of the jetd broke but remained intact with the rest of the catheter.It was reported that the physician removed the jetd carefully from the patient, without issue.The procedure was completed using a new jetd and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this report was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was discarded.Therefore, without the return of the device, the root cause of the problem cannot be determined.Based on this information, corrections were made to: section d.Box 10.Device available for evaluation? (do not send to fda).Section h.Box 3.Reason for non-evaluation.Section h.Box 3.''other'' reason for non-evaluation.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 JETD REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10792357
• Report Number: 3005168196-2020-01893
• Device Sequence Number: 3694277
• Product Code: NRY
• UDI-Device Identifier: 00814548019802
• UDI-Public: 00814548019802
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K090752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2022
• Device Model Number: 5MAXJETDKIT
• Device Catalogue Number: 5MAXJETDKIT
• Device Lot Number: F93997
• 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: 10/08/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005