MAUDE Adverse Event Report: PENUMBRA, INC. 5MAX REPERFUSION CATHETER; NRY

Model Number	PSC054-B
Medical Device Problem Codes	Stretched (1601); Aspiration Issue (2883)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2017
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 middle cerebral artery (mca) using 5max reperfusion catheters (5max).During the procedure, the physician advanced a 5max in the target vessel with no issue using a non-penumbra 6f sheath.While attempting to aspirate the thrombus using the adapt technique, the physician noticed that there was no clot coming back in the canister.However, the physician was certain that the clot was already captured at the distal tip of the 5max; therefore, the 5max was slowly pulled back.It was reported that the physician felt less tension than usual while removing the 5max.Upon removal, the physician noticed that the distal end of the 5max was flattened and stretched.Therefore, the 5max was set aside and the procedure was completed using a new 5max and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The 5max reperfusion catheters (5maxc) was fractured approximately 131.0 cm from the hub, with necking of the catheter shaft visible just proximal and distal to the fracture.The 5maxc was kinked in multiple locations along its proximal shaft.Evaluation of the returned device revealed the 5maxc was fractured and necked down near the fracture.It is possible for the 5maxc to become pinned against patient anatomy and other devices in the procedure.If the 5maxc becomes pinned or otherwise restrained and is subsequently forcefully retracted, the 5maxc may become necked and fractured.The reported lack of aspiration may have occurred due to clot occluding the distal tip, as was also reported in the complaint.Further evaluation revealed the 5maxc was kinked in multiple locations along its proximal shaft.This damage may have occurred due to forceful handling during attempts to withdraw the 5maxc.The non-penumbra sheath mentioned in the complaint was not returned for evaluation.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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report:3005168196-2017-01405.Section d.Box 4.Expiration date.

• Brand Name: 5MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6811567
• Report Number: 3005168196-2017-01405
• Device Sequence Number: 19349474
• Product Code: NRY
• UDI-Device Identifier: 00814548012742
• UDI-Public: 00814548012742
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2017
• 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: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: PSC054-B
• Device Catalogue Number: PSC054
• Device Lot Number: F65763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 07/25/2017; 01/14/2005
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 09/29/2017; 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005