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

Catalog Number	5MAXJET7KIT
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
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 jet7 reperfusion catheter (jet7), a non-penumbra sheath, and a guidewire.It was noted that the patient¿s cervical carotid artery was curved.During the procedure, the physician advanced the sheath to the proximal cervical carotid artery curve.The physician then steamed shaped the jet7 and advanced it over the guidewire through the sheath and into the level of the clot.After initiation of the aspiration during the first pass, the physician noticed that no clots were being retrieved and decided to remove the jet7.While retracting the jet7, the jet7 kinked and became stuck within the sheath.The physician then applied more force to pull the jet7 out and consequently, fractured the jet7.Subsequently, only the proximal end of the jet7 was removed.It was reported that the distal segment of the jet7 was still at the level of the clot.Afterwards, the physician retracted the sheath and, the distal segment of the jet7 came out along with it.After removal from the patient, the physician was unable to easily remove the distal segment of the jet7 from the sheath and used forceps to remove it.The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68), the same non-penumbra sheath, and a stent retriever.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned jet7 confirmed that the catheter was fractured.Evaluation revealed kinks and stretching near the fractured location.If the jet7 is advanced against resistance, it may get stuck within the guide catheter and may fracture the device upon subsequent retraction.The additional kinks near the fractured location and the stretching likely occurred due to forceful retraction against resistance.The reported patient¿s curved carotid anatomy likely contributed to resistance during the procedure.Further evaluation revealed a kink on the proximal shaft.This damage was incidental to the reported complaint.Based on the returned condition, the root cause of the initial kink mentioned in the complaint could not be determined.Penumbra products are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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 jet7 reperfusion catheter (jet7), a non-penumbra sheath, and a guidewire.It was noted that the patient¿s cervical carotid artery was curved.During the procedure, the physician advanced the sheath to the proximal cervical carotid artery curve.The physician then steamed shaped the jet7 and advanced it over the guidewire through the sheath and into the level of the clot.After initiation of the aspiration during the first pass, the physician noticed that no clots were being retrieved and decided to remove the jet7.While retracting the jet7, the physician experienced resistance and the jet7 would not move at all.It was reported that jet7 was kinked during the initial advancement through the curve of the cervical carotid artery but the physician did not notice the kink.The physician then applied more force to pull the jet7 out and consequently, fractured the jet7.Subsequently, only the proximal end of the jet7 was removed and the distal segment of the jet7 remained at the level of the clot.Afterwards, the physician retracted the sheath and the distal segment of the jet7 came out along with it.After removal from the patient, the physician was unable to easily remove the distal segment of the jet7 from the sheath and used forceps to remove it.The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68), the same non-penumbra sheath, and a stent retriever.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16710375
• Report Number: 3005168196-2023-00164
• Device Sequence Number: 15302882
• Product Code: NRY
• UDI-Device Identifier: 00814548019925
• UDI-Public: 814548019925
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023
• 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: 02/01/2024
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: C00001067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005