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	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
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 advanced a 3maxc over a penumbra system ace 68 reperfusion catheter (ace 68) through a non-penumbra guidewire and tracked into the target vessel.As the guidewire was being retracted, the physician felt resistance and the physician pulled the 3maxc back despite the resistance.Upon removal, the physician noticed that the 3maxc was fractured at the mid-shaft; therefore, the 3maxc was removed.The procedure was completed using the same ace 68, guidewire and a new 3maxc.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the 3maxc was fractured approximately 106.5 cm from the hub.The polymer on both sides of the fracture site had yield marks.Conclusions: evaluation of the returned 3maxc revealed that the catheter was fractured.If the 3maxc is advanced against resistance, damage such as a kink may occur.If a kinked device is further manipulated against resistance, the kink may worsen to a fracture.Further evaluation revealed yield marks on both sides of the fracture site.This indicates that the fracture likely occurred as a result of a kink.The ace68 and non-penumbra guide wire identified in the complaint were not returned to penumbra for evaluation.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.Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2019-01316.
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 advanced a penumbra system ace 68 reperfusion catheter (ace68) over a 3maxc, over a non-penumbra guidewire and tracked into the target vessel.As the guidewire was being retracted, the physician felt resistance and the physician pulled the 3maxc back despite the resistance.Upon removal, the physician noticed that the 3maxc was fractured at the mid-shaft; therefore, the 3maxc was removed.The procedure was completed using the same ace68, guidewire and a new 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: 8761252
• Report Number: 3005168196-2019-01316
• Device Sequence Number: 1488845
• 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,Followup
• Report Date (Section B): 06/07/2019
• 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: 03/03/2022
• Device Catalogue Number: 3MAXC
• Device Lot Number: F88813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Date Report Sent to FDA: 01/01/2005