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

Model Number	4MAXC
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 m2 segment of the middle cerebral artery using a penumbra system 4max reperfusion catheter (4maxc) and a non-penumbra guiding sheath.During the procedure, while inserting the 4maxc into the guiding sheath, the physician experienced resistance.Subsequently, the physician kinked the proximal end of the 4maxc; therefore, the 4maxc was removed.The procedure was completed using a new 4maxc and the same guiding sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned 4maxc confirmed a kink near its proximal end.If the device is forcefully advanced against resistance, damage such as this may occur.Evaluation also revealed an ovalization in its mid-shaft.If the device is forcefully pinched or gripped during use, damage such as this may occur.This ovalization likely contributed to the resistance experienced during the procedure.During functional testing, the 4maxc was able to advance through a demonstration neuron max with resistance due to the ovalization in its mid-shaft.Further evaluation of the device also revealed additional kinks in the proximal shaft and an additional ovalization in the distal shaft.Based on the complaint, this damage was likely incidental.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 4MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12465496
• Report Number: 3005168196-2021-02030
• Device Sequence Number: 17088659
• Product Code: NRY
• UDI-Device Identifier: 00814548012414
• UDI-Public: 00814548012414
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021
• 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: 11/30/2023
• Device Model Number: 4MAXC
• Device Catalogue Number: 4MAXC
• Device Lot Number: F102369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005