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

Catalog Number	4MAXC
Medical Device Problem Codes	Kinked (1339); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2016
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 using a penumbra system 4max reperfusion catheter (4max).During the procedure, the physician advanced the 4max through a non-penumbra sheath and then attempted to advance a veloicty delivery microcatheter (velocity) through the 4max.However, the velocity was unable to advance through the 4max.Therefore, the physician removed the 4max and velocity from the patient and noticed that the 4max was kinked upon inspection.The procedure was then completed using a new 4max, the same velocity and the same non-penumbra sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The penumbra system 4max reperfusion catheter (4max) was kinked approximately 51.0 cm from the hub.The 4max was ovalized approximately 63.0 and 105.0 cm from the hub.The 4max was bent 17.0 and 89.0 cm from the hub.Evaluation of the 4max revealed damage at multiple locations along the catheter shaft.The 4max kink was confirmed during evaluation and likely contributed to the inability to advance the velocity, as experienced by the physician.Further evaluation revealed ovalizations and bends in the 4max catheters.The ovalizations were likely a result of repeated attempts to manipulate the kinked 4max prior to removal for inspection.The bends in the 4max were likely incidental and likely occurred during packaging for return to penumbra.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.

• 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: 6024801
• Report Number: 3005168196-2016-01450
• Device Sequence Number: 270645
• Product Code: NRY
• UDI-Device Identifier: 00814548012414
• UDI-Public: 00814548012414
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133317
• 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): 09/13/2016

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: 05/26/2019
• Device Catalogue Number: 4MAXC
• Device Lot Number: F69510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2016
• Supplement Report FDA Received Date: 11/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1