MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER; NRY

Model Number	5MAXJET7KIT
Medical Device Problem Codes	Material Deformation (2976); 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	10/06/2020
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), non-penumbra stent retrievers, a non-penumbra sheath, a non-penumbra microcatheter and a guidewire.Prior to the procedure, it was noted that there was dissection in the carotid artery, which made access to the target vessel difficult.During the procedure, the physician advanced the jet7, microcatheter and stent retriever device through the parent catheter and into the target vessel.After completion of a pass, the physician removed the microcatheter and pulled the stent retriever device through the jet7.The physician did not want to lose access and therefore, left the jet7 in place.While advancing another stent retriever device through the jet7, the physician experienced resistance.After completion of another pass, the physician was unable to remove the stent retriever device and therefore, removed the jet7 and stent retriever device as a unit.Upon removal, the physician noticed that the jet7 accordioned.It was also reported that a contrast run was performed through the jet7 at some point.The procedure was completed using a new jet7, a new microcatheter, a new stent retriever device and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
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 disposed of and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.H3 other text: placeholder.

• Brand Name: PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10788921
• Report Number: 3005168196-2020-01886
• Device Sequence Number: 14486863
• Product Code: NRY
• UDI-Device Identifier: 00814548019925
• UDI-Public: 00814548019925
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 10/06/2020
• 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 Model Number: 5MAXJET7KIT
• Device Catalogue Number: 5MAXJET7KIT
• 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: 10/06/2020
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Date Report Sent to FDA: 01/01/2005