MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Catalog Number	3MAXC
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 numbers: 3005168196-2019-00912; 3005168196-2019-00914.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the basilar artery using a penumbra system jet 7 reperfusion catheter (jet7) from a penumbra system jet7 kit, and a penumbra system 3max reperfusion catheter (3maxc).It should be noted that the patient's anatomy was tortuous.During the procedure, while attempting to track a jet7 over the 3maxc to make the first pass, the physician experienced resistance and subsequently, the jet7 was unable to advance any further.The jet7 was therefore removed and was no longer used in the procedure.The physician then attempted to track another jet7 over the same 3maxc and the same issue occurred.This jet7 was also removed and was no longer used in the procedure.It was also reported that upon retraction of the 3maxc during the second pass the physician experienced resistance and subsequently, the 3maxc became kinked approximately 20 cm from the distal end.The 3maxc was therefore removed and the procedure was continued using a penumbra system ace 68 reperfusion catheter (ace68) and another 3maxc.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8596223
• Report Number: 3005168196-2019-00915
• Device Sequence Number: 19406803
• Product Code: NRY
• UDI-Device Identifier: 00814548019932
• UDI-Public: 00814548019932
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 04/10/2019
• 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: 02/04/2021
• Device Catalogue Number: 3MAXC
• Device Lot Number: F81767
• Was Device Available for Evaluation?: No
• 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: 04/10/2019
• Initial Report FDA Received Date: 05/09/2019
• 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