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

Catalog Number	3MAXC
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the returned 3maxc was kinked at approximately 5.0 cm and 45.0 cm from the hub.The device was fractured at approximately 50.0 cm from the hub.Yield marks were present near the catheter fracture site.The device was ovalized at approximately 129.0 cm, 132.0 cm, 136.0 cm and 156.0 cm from the hub.Conclusions: evaluation of the returned 3maxc confirmed a fracture and revealed yield marks near the site of the fracture.These yield marks indicate that the device was kinked prior to become fractured.If the device is forcefully advanced against resistance, it may become kinked.Subsequently retracting the kinked device against resistance may result in the device fracture.No other devices indicated in the complaint were returned for evaluation; therefore, the root cause of the resistance was unable to be determined.Further investigation revealed kinks and ovalizations on the catheter.These damages were likely incidental to the complaint and could have occurred during removing the device from the procedure.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc).During the procedure, the physician placed a guide catheter and attempted to advance a non-penumbra reperfusion catheter together with a 3maxc; however, the physician had difficulty advancing past the ophthalmic with the reperfusion catheter.Therefore, the 3maxc was retracted and became fractured.The physician pulled the coil wind and successfully removed the remaining parts of the 3maxc.There was no report of an adverse effect to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: 9453010
• Report Number: 3005168196-2019-02299
• Device Sequence Number: 3077857
• Product Code: NRY
• UDI-Device Identifier: 00814548019932
• UDI-Public: 00814548019932
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 11/15/2019
• 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: 07/09/2022
• Device Catalogue Number: 3MAXC
• Device Lot Number: F91644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• 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: 11/15/2019
• Initial Report FDA Received Date: 12/11/2019
• 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