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

Catalog Number	4MAXC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the 4max was ovalized approximately 41.0 and 78.0 cm from the hub.The 4max was kinked approximately 86.0 cm from the hub.Conclusions: evaluation of the returned 4max revealed a kink and two ovalizations along the length of the device.No holes or leaks were found on the returned device.As the reported puncture hole from the guidewire could not be found, the root cause of the reported failure could not be determined.The kink and ovalizations found on the returned device may have been a result of forceful mishandling during use or preparation for the procedure.Penumbra catheters are visually 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the basilar artery/right posterior cerebral artery (pca) using a penumbra system 4max reperfusion catheter (4maxc).During the procedure, the physician advanced a 4maxc through a neuron max 6f 088 long sheath (neuron max) over a non-penumbra guidewire.The physician then brought the guidewire back into the 4maxc to torque it and advance into the right pca.However, the guidewire went through the side of the 4maxc and was no longer coming out of the distal end of the 4maxc; therefore, the 4maxc and guidewire were removed.The procedure was completed using a new 4maxc, the same neuron max and guidewire.There was no report of an adverse effect to the patient.

• 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: 7494931
• Report Number: 3005168196-2018-00946
• Device Sequence Number: 10811640
• Product Code: NRY
• UDI-Device Identifier: 00814548012414
• UDI-Public: 00814548012414
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

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: 10/22/2020
• Device Catalogue Number: 4MAXC
• Device Lot Number: F80138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 98