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

Model Number	5MAXJET7KIT-B
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the jet7 was ovalized approximately 24.5 cm from the hub.The jet7 was stretched approximately 129.0 cm from the hub.Conclusions: evaluation of the returned jet7 revealed that the distal shaft was stretched.If the jet7 is forcefully manipulated against resistance, damage such as stretching may occur.During decontamination, while flushing the jet7 the distal shaft expanded.During the functional test, resistance was encountered due to the stretched distal shaft bunching up inside the hub of the demonstration neuron max, and the jet7 could not be advanced any further.Further evaluation of the returned jet7 revealed an ovalization on the proximal shaft.This damage was incidental to the reported complaint.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 m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), a non-penumbra sheath and a non-penumbra stent retriever.During the procedure, the physician completed approximately two to three passes using the jet7 and for the last pass a stent retriever was used.Afterwards, the jet7 was removed and while the technician flushed the jet7 on the back table, it was noticed that the distal tip of the jet7 expanded.Therefore, the jet7 was not used for the remainder of the procedure.The procedure was completed using another device and the same sheath.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: 10903547
• Report Number: 3005168196-2020-02102
• Device Sequence Number: 14130494
• 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: 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
• Report Date (Section B): 10/27/2020
• 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: 01/21/2023
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F95680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• 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: 10/27/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005