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	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 internal carotid artery (ica) and the m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), velocity delivery microcatheter (velocity), non-penumbra stent retriever, and non-penumbra sheath.During the procedure, the physician completed several passes using the jet7, velocity, and non-penumbra stent retriever.Subsequently, the jet7, velocity, and stent retriever were removed to be flushed.However, the physician noticed the distal end of the jet7 to be stretched with slight discoloration on the back table.Therefore, the jet7 was not used for the remainder of the procedure.The procedure was completed using a penumbra system jetd reperfusion catheter (jetd) with the same velocity, stent retriever, and sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the jet7 had multiple kinks approximately 122.0 cm, 125.0 cm, 127.0 cm, and 129.0 cm from the hub.The device was ovalized approximately 16.0 cm, 81.0 cm, 88.0 cm, and 101.0 cm from the hub.The total length of the returned jet7 was approximately 132.5 cm.Conclusions: evaluation of the returned jet7 revealed multiple kinks on its distal shaft.This damage was likely the reported the distal tip stretched with slight discoloration.If the stent retriever is manipulated through the jet7, resistance may be encountered and damage such as distal kinks may occur.During functional testing, the jet7 was unable to advance through a demonstration neuron max due to the ovalization on the jet7 and a demonstration lantern was able to advance through the jet7 with resistance due to the ovalization on the jet7.The ovalization on the jet7 was likely incidental to the complaint and may have occurred during packaging for the device returned.Penumbra catheters are 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.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
• MDR Report Key: 10963181
• Report Number: 3005168196-2020-02209
• Device Sequence Number: 909978
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: 00815948020962
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 11/12/2020
• 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: 11/16/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Date Report Sent to FDA: 01/01/2005