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

Model Number	5MAXJET7KIT-B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the jet7 was fractured approximately 1.0 cm from the hub underneath the strain relief.Conclusions: evaluation of the returned jet7 confirmed a leak underneath the strain relief.During decontamination, the jet7 was flushed with air while submerged in the bleach solution, and bubbles were observed coming from the strain relief.The strain relief was unraveled, and a fracture was observed underneath the strain relief.If the proximal end of the jet7 is forcefully manipulated during use, damage such a fracture may occur.This fracture contributed to the leak on the jet7 during the procedure and the functional test.Penumbra catheters 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 middle cerebral artery (mca) using a penumbra system jet7 reperfusion catheter (jet7), a velocity delivery microcatheter (velocity) and a neuron max 6f 088 long sheath (neuron max).During the procedure, while advancing the jet7, velocity and neuron max through the patient¿s vessel prior to any passes, the physician noticed the proximal end next to the hub of the jet7 was leaking saline.Therefore, the jet7 was removed.The procedure was completed using a new jet7 and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference number: (b)(4).The following sections are being updated based on additional information included in the user facility report submitted to the fda: 1.Section b.Box 5.Describe event or problem; 2.Section e.Box 4.Initial reporter also sent report to fda; 3.Section g.Box 3.Report source.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system jet7 reperfusion catheter (jet7), a velocity delivery microcatheter (velocity) and a neuron max 6f 088 long sheath (neuron max).During the procedure, while advancing the jet7, velocity and neuron max through the patient¿s vessel prior to any passes, the physician noticed the proximal end next to the hub of the jet7 appeared to be stretched and was leaking saline.Therefore, the jet7 was removed.The procedure was completed using a new jet7 and the same neuron max.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
• MDR Report Key: 11143278
• Report Number: 3005168196-2021-00048
• Device Sequence Number: 700817
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: 00815948020962
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202251
• 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): 12/11/2020
• 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: 02/03/2023
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F96046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005