MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER; NRY

Model Number	J7XKIT132-A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: multiple kinks were present along the jet7 approximately 109.5 - 114.0, 116.5 ¿ 124.0 and 132.5 cm from the hub.Conclusions: evaluation of the returned max dd confirmed resistance while manipulating a guidewire within its lumen.Further evaluation revealed a distal shaft ovalization and the jet7 had multiple kinks along the distal shaft.If the devices are forcefully manipulated against resistance, damage such as this may occur.During functional testing, the max dd was advanced through the jet7 with resistance.Subsequently, a demonstration guidewire was advanced through the max dd with resistance.The ovalization in the max dd may have contributed to resistance experienced during the procedure and the functional test.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.This report is associated with mfr report number: 3005168196-2020-01289.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) using a max delivery device (max device).During the procedure, the physician experienced resistance while advancing the guidewire through the max device; however, the guidewire was still able to be used with the max device.It was also reported that the max device became stuck upon removal from the jet7 and felt like a spring.The physician completed the procedure using the same guidewire and max device.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10693592
• Report Number: 3005168196-2020-01780
• Device Sequence Number: 3934012
• Product Code: NRY
• UDI-Device Identifier: 00815948021273
• UDI-Public: 00815948021273
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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): 09/17/2020
• 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: 03/31/2021
• Device Model Number: J7XKIT132-A
• Device Catalogue Number: J7XKIT132
• Device Lot Number: C21487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• 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: 09/17/2020
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Date Report Sent to FDA: 01/01/2005