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

Model Number	5MAXJETDKIT-A
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
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.Additional 510(k)that also apply to this complaint: k133317.This report is associated with mfr report numbers: 3005168196-2019-02446, 3005168196-2019-02447.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) using a penumbra system jetd reperfusion catheter (jetd), neuron max 6f 088 long sheath (neuron max) and, velocity delivery microcatheter (velocity).During the procedure, the physician placed a neuron max in the left internal carotid artery (ica), a velocity was then used to bring up the jetd through the neuron max and into the target vessel.Afterward, the physician removed velocity; however, resistance was encountered while retracting the velocity out from the jetd.It was reported that the physician thought there might be something wrong with the jetd; therefore, it was removed.However, while retracting the jetd out of the neuron max, the physician experienced resistance and the jetd proximal end began to collapse.The physician also thought there might something wrong with the neuron max distally; therefore, the neuron max was also removed.The procedure was completed using a new jetd, neuron max and the same velocity.It was also reported that after the procedure, the first neuron max was examined, and the distal end was found to be kinked.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the jetd was ovalized from approximately 20.0 ¿ 47.0, 97.5 ¿ 98.0 and 99.5 cm from the hub.The device was kinked from approximately 136.0 ¿ 137.5 cm from the hub.Conclusions: evaluation of the returned jetd confirmed an ovalization on the distal shaft.If the neuron max became kinked while the jetd was inserted into the device and the jetd is retracted, damage such as an ovalization may occur.In addition, resistance may also be experienced during retraction of the jetd out of the neuron max.Further evaluation revealed additional ovalizations on the proximal end of the jetd.If the device is retracted from the neuron max at extreme angles outside of the patient, damage such as ovalizations may occur.During functional testing, resistance was experienced while advancing the jetd through a demonstration neuron max due to the proximal ovalization and the jetd could not advance any further.Evaluation of the returned neuron max confirmed a kink on the distal shaft.If the device is advanced against resistance, damage such as a kink may occur.During functional testing, resistance was experienced while attempting to advance the returned jetd through the neuron max due to the kink and the jetd could not be advanced any further.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.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 numbers: 1.3005168196-2019-02446 2.3005168196-2019-02447.

• Brand Name: PENUMBRA SYSTEM JETD REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9539354
• Report Number: 3005168196-2019-02445
• Device Sequence Number: 19493455
• Product Code: NRY
• UDI-Device Identifier: 00814548019741
• UDI-Public: 00814548019741
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K090752
• 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): 12/10/2019
• 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 Model Number: 5MAXJETDKIT-A
• Device Catalogue Number: 5MAXJETDKIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 02/13/2020
• 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