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

Model Number	5MAXJET7KIT-B
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-02105.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a penumbra system jet 7 reperfusion catheter (jet7) and benchmark bmx96 access system (benchmark max).During the procedure, the physician attempted to aspirate through the benchmark max with a 10cc syringe but was unable to aspirate fluid.Therefore, the physician did not attempt to inject contrast through the benchmark max around the jet7.The jet7 was subsequently removed.Upon removal, the distal end of the jet7 was observed to be kinked.The procedure ended at this point.A thrombolysis in cerebral infarction (tici) grade 2b recanalization was achieved with two passes using the jet7.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a penumbra system 3max reperfusion catheter (3maxc), a penumbra system jet 7 reperfusion catheter (jet7) and benchmark bmx96 access system (benchmark max).During the procedure, the physician attempted to aspirate through the benchmark max with a 10cc syringe but was unable to aspirate fluid.Therefore, the physician did not attempt to inject contrast through the benchmark max around the jet7.The jet7 was subsequently removed.Upon removal, the distal end of the jet7 was observed to be kinked.The procedure ended at this point.A thrombolysis in cerebral infarction (tici) grade 2b recanalization was achieved with two passes using the jet7.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned benchmark max revealed a functional device.During the functional test, a demonstration jet7 was advanced through the returned benchmark max without an issue.The benchmark max was then flushed with the demonstration jet7 through its lumen without an issue.Therefore, the reported complaint could not be confirmed.Evaluation of the returned jet7 confirmed that the catheter was kinked.The root cause of the device becoming kinked could not be determined.Further evaluation of the returned jet7 revealed a fracture.Based on the lack of stretching near the fracture site, this damage was likely the result of a kink.This damage was incidental to the reported complaint.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report number: 3005168196-2020-02105.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10907118
• Report Number: 3005168196-2020-02106
• Device Sequence Number: 1153949
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: 00815948020962
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K190010
• 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): 10/30/2020
• 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: 01/27/2023
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F95870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Date Report Sent to FDA: 01/01/2005