MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER; NRY

Model Number	4MAXCKIT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned 4maxc confirmed that the catheter was ovalized.If the 4maxc is forcefully gripped or pinched during use, damage such as ovalizations may occur.During the functional test, resistance was encountered while attempting to advance the 4maxc through a demonstration neuron max due to the ovalization in the catheter shaft, and the 4maxc could not be advanced any further.Resistance was also encountered while attempting to advance a velocity through the 4maxc due to the ovalization in distal shaft of the 4maxc, and the velocity could not be advanced any further.Evaluation also revealed additional ovalization throughout the length of the catheter.This damage was incidental to the reported complaint and likely occurred during use.Evaluation of the first velocity revealed that the strain relief was stretched.If the distal end of the strain relief is pinned within the rhv and the catheter is retracted, damage such as a stretched strain relief may occur.During the functional test, the velocity was advanced through a demonstration 4maxc without an issue.Resistance was encountered while attempting to advance the velocity through the returned 4maxc due to the ovalization in the distal shaft, and the velocity could not be advanced any further.Evaluation also revealed bends in the catheter shaft.This damage was incidental to the reported complaint and may have occurred during use.Evaluation of the second velocity revealed that the strain relief was stretched.If the distal end of the strain relief is pinned within the rhv and the catheter is retracted, damage such as a stretched strain relief may occur.Further evaluation revealed ovalization on the distal shaft.This damage was incidental to the reported complaint and may have occurred during use.During the functional test, resistance was encountered while attempting to advance the velocity through a demonstration 4maxc due to the ovalization in the distal shaft of the 4maxc, and the velocity could not be advanced any further.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report numbers: 3005168196-2021-01825, 3005168196-2021-01826.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left internal carotid artery (ica), left middle cerebral artery (m1, m2) and left anterior cerebral artery (a2) using a velocity delivery microcatheter (velocity), a penumbra system 4max reperfusion catheter (4maxc), a non-penumbra catheter, a non-penumbra stent retriever and a non-penumbra guidewire.During the procedure, the physician had difficulty advancing the velocity within the non-penumbra catheter and the stent retriever into the left m1 with m2 as the target location.Therefore, the velocity and the catheter were removed and the second velocity was opened along with 4maxc.While advancing the 4maxc with the second velocity using a guidewire, the physician encountered resistance and had difficulty advancing the second velocity as well.However, the physician was able to perform thrombectomy in the m2 successfully.The physician then tried to advance the velocity to the next target location (left a2); however he again had difficulty advancing the velocity to the target location.Therefore, the velocity was removed and replaced by a non-penumbra microcatheter.After removal, the physician noted that the proximal end of both velocities were stretched and the 4maxc was ovalized at the distal end.It was reported that reperfusion was achieved but the patient experienced carotid dissection; however, the physician did not attribute the carotid dissection to any of the penumbra devices used in the procedure.At this point the physician decided to quit the procedure because he couldn¿t advance the non-penumbra microcatheter through the 4maxc.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12338986
• Report Number: 3005168196-2021-01827
• Device Sequence Number: 4980811
• Product Code: NRY
• UDI-Device Identifier: 00814548016740
• UDI-Public: 00814548016740
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• 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): 08/18/2021
• 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: 01/22/2024
• Device Model Number: 4MAXCKIT
• Device Catalogue Number: 4MAXCKIT
• Device Lot Number: F103435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• 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: 07/24/2021
• Initial Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005