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

Catalog Number	3MAXC-A
Medical Device Problem Codes	Unraveled Material (1664); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2019
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 in the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc).During the procedure, while advancing the 3maxc into a penumbra system jet 7 reperfusion catheter (jet7) and a neuron max 6f 088 long sheath (neuron max), the 3maxc coiled up inside of the jet7.Therefore, the physician then attempted to remove the 3maxc; however, while retracting, it became unraveled upon removal.The procedure was then completed using a new 3maxc with the same jet7 and neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the 3maxc was kinked approximately 5.0, 7.0, 35.5 cm from the hub.The 3maxc was stretched from approximately 141.5 thru 152.0 cm from the hub.During functional testing, the stretched distal shaft of the 3maxc could not be advanced through the hub of a demonstration jet7.The 3maxc could not be advanced any further.Conclusions: evaluation of the returned 3maxc revealed that the catheter was stretched.If the 3maxc is forcefully retracted against resistance, damage such as stretching may occur.The reported 3maxc coiling up within the jet7 likely contributed to the resistance experienced during retraction.The jet7 and neuron max identified in the complaint were not returned for evaluation.Further evaluation of the returned 3maxc revealed kinks.These kinks were likely incidental to the reported complaint.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.

• 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: 9098518
• Report Number: 3005168196-2019-01794
• Device Sequence Number: 19474994
• Product Code: NRY
• UDI-Device Identifier: 00814548019932
• UDI-Public: 00814548019932
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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): 08/23/2019
• 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: 04/08/2022
• Device Catalogue Number: 3MAXC-A
• Device Lot Number: F89447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005