MAUDE Adverse Event Report: PENUMBRA, INC. MAX DELIVERY DEVICE; NRY

Model Number	J7XKIT132-A
Medical Device Problem Codes	Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
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 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.
Additional Manufacturer Narrative
Results: the max dd was ovalized approximately 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: 1.3005168196-2020-01780.

• Brand Name: MAX DELIVERY DEVICE
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10456797
• Report Number: 3005168196-2020-01289
• Device Sequence Number: 3524222
• 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: K191946
• 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): 07/28/2020
• 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
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement 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