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

Model Number	5MAXJET7BKIT-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) using a penumbra system jet7 reperfusion catheter (jet7), a velocity delivery microcatheter (velocity) a benchmark bmx96 access system (benchmark max) and a penumbra engine (engine).During the procedure, the physician advanced a jet7 over a velocity through the benchmark max to the face of the clot and then removed velocity.The physician then connected the jet7 to the engine and initiated aspiration.After three minutes under aspiration, the physician decided to remove the jet7.While pulling back the jet7, the physician noticed that the distal end of the jet7 was not moving.It was reported that the physician did not experience any resistance.The physician continued to pull the jet7 and the distal end of the jet7 was still not moving; however, the jet7 was being pulled out of the hub of the benchmark max.After the removal of the jet7, it was noticed that approximately ten centimeters from the distal end of the jet7 had broken off intracranially.Next, the benchmark max was removed and it was noticed that there was a slit on the distal end of the benchmark max.Afterwards, the physician attempted to remove the broken distal end of the jet7 using a snare device but was unsuccessful because the broken distal end of the jet7 had prolapsed into the external carotid artery.Consequently, the physician performed an open surgery via carotid cutdown technique to successfully remove the broken distal end of the jet7.The procedure was then completed by finishing the thrombectomy procedure using another aspiration catheter.It was also reported that the patient is doing well and is improving.
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: 3005168196-2021-02558.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) using a penumbra system jet7 reperfusion catheter (jet7), a velocity delivery microcatheter (velocity) a benchmark bmx96 access system (benchmark max) and a penumbra engine (engine).During the procedure, the physician advanced a jet7 over a velocity through the benchmark max to the face of the clot and then removed velocity.The physician connected the jet7 to the engine and initiated aspiration.After three minutes under aspiration, the physician decided to remove the jet7.While pulling back the jet7, the physician noticed that the distal end of the jet7 was not moving.It was reported that the physician did not experience any resistance.After the removal of the jet7, it was observed that the jet7 had fractured.Attempts to remove the fractured jet7 segment using a snare device were unsuccessful because the broken distal end of the jet7 had prolapsed into the external carotid artery.Damage to the distal tip of the benchmark max was observed upon removal.Open surgery was performed via carotid cutdown technique to successfully remove the fractured jet7.The procedure was then completed by finishing the thrombectomy procedure using another aspiration catheter.It was also reported that the patient is doing well and is improving.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 11/19/2021: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned jet7 confirmed a fracture approximately 20 cm from the distal tip.Evaluation revealed stretching immediately proximal to the fractured location.This damage typically occurs if the device is retracted against resistance.Evaluation also revealed kinks distal to the fractured location and an ovalization proximal to the fractured location.Evaluation of the returned bmx96 confirmed damage to the distal tip.This damage may be incidental to the reported complaint and may have occurred during jet7 retrieval attempts and removal from the patient.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.This report is associated with mfr report number: 3005168196-2021-02558.H3 other text: placeholder.

• 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: 12799845
• Report Number: 3005168196-2021-02557
• Device Sequence Number: 14738248
• Product Code: NRY
• UDI-Device Identifier: 00815948023246
• UDI-Public: 00815948023246
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/14/2021
• 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: 02/11/2024
• Device Model Number: 5MAXJET7BKIT-A
• Device Catalogue Number: 5MAXJET7BKIT
• Device Lot Number: F103849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• 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: 10/20/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005