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

Catalog Number	3MAXC
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the returned 3maxc was fractured at approximately 150.0 cm from the hub.The device was ovalized from approximately 148.0 cm to 150.0 cm from the hub.The fractured distal portion was not returned with the device.Conclusions: evaluation of the two returned 3maxcs confirmed a fracture and revealed an ovalization next to the fracture site.These damages are typically a result of forcefully retracting the device against resistance.The ace68 identified in the complaint was not returned for evaluation; therefore, the root cause of the resistance could not be determined.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report number: 3005168196-2019-01806.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using penumbra system 3max reperfusion catheters (3maxcs).During the procedure, the physician successfully advanced a 3maxc through a penumbra system ace 68 reperfusion catheter (ace68) to the target location.When the 3maxc was being retracted from the ace68, the physician experienced resistance.Upon removal of the 3maxc from the tuohy, the 3maxc fractured into two pieces.The physician then used hemostat forceps to remove the remaining piece of 3maxc from the ace68.Therefore, the 3maxc was completely removed from the procedure.The physician continued the procedure using another 3maxc, however, the same issue occurred.This 3maxc was also removed and was no longer used in the procedure.The procedure was completed using a third 3maxc and the same ace68.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: 9112531
• Report Number: 3005168196-2019-01807
• Device Sequence Number: 1782354
• Product Code: NRY
• UDI-Device Identifier: 00814548019932
• UDI-Public: 00814548019932
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 08/28/2019
• 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: 11/14/2021
• Device Catalogue Number: 3MAXC
• Device Lot Number: F87046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• 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: 08/28/2019
• Initial Report FDA Received Date: 09/24/2019
• 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