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

Catalog Number	4MAXCKIT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2019
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.This report is associated with mfr report number: 3005168196-2019-01236.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the distal m2 and m3 segment of the middle cerebral artery (mca) using penumbra system 4max reperfusion catheters (4maxc)s.During the procedure, the physician found the mid shaft of the first 4maxc to be ovalized and flattened while under aspiration and pulling out the non-penumbra stent retriever.Therefore, the 4maxc was removed.The physician then used a new 4maxc; but, the same issue occurred; therefore, it was removed.The procedure was completed using a new 4maxc and the same stent retriever.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the 4maxc was kinked approximately 22.0 cm from the hub.The device was ovalized from approximately 22.0 ¿ 47.5 cm from the hub.The total length was approximately 139.0 cm.Conclusions: evaluation of the two returned 4maxc¿s confirmed ovalizations and revealed kinks at the proximal ends of the ovalizations.If the devices are manipulated from a parent catheter at extreme angles, damage such as kinks may occur.If a kinked device is further manipulated at extreme angles, damage such as ovalizations may occur.During functional testing, water was able to be aspirated through both returned 4maxcs.A stainless-steel mandrel was unable to be advanced through either of the returned devices.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.(b)(4).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: 8739796
• Report Number: 3005168196-2019-01237
• Device Sequence Number: 2473593
• Product Code: NRY
• UDI-Device Identifier: 00814548016740
• UDI-Public: 00814548016740
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 05/28/2019
• 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 Expiration Date: 09/16/2021
• Device Catalogue Number: 4MAXCKIT
• Device Lot Number: F85851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/28/2019
• 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