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

Catalog Number 3MAXC

Device Problems Retraction Problem (1536); Defective Device (2588); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event 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 non-penumbra stent retriever, however, then was experiencing difficulty retracting it out of the patient.The physician therefore advanced the 3maxc over the proximal end of the stent retriever¿s pusher assembly and attempted to retract the stent retriever into the 3maxc.While retracting, the physician felt significant resistance and, consequently, the stent retriever became lodged within the 3maxc.The physician therefore removed the 3maxc with the stent retriever inside.Upon removal, the physician saw that the 3maxc was damaged.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the 3max was kinked approximately 7.0 cm from the hub.The 3max was began stretching and necking down at approximately 139.0 cm from the hub and fractured approximately 149.0 cm from the hub.The distal fractured portion of the 3max was approximately 9.0 cm long and is not stretched.The non-penumbra stent retriever was lodged within the 3max and was visible within the lumen approximately 2.0 cm from the 3max fracture.The 3max was fractured and the non-penumbra stent retriever was stuck within its lumen.The device was unable to be flushed and the non-penumbra stent retriever was unable to be removed from the 3max.The 3max was unable to be functionally tested.Conclusions: evaluation of the returned 3max revealed a stretched and fractured device with a non-penumbra stent retriever lodged within its lumen.Per the complaint report, the stent retriever was stuck within patient anatomy.If the 3max is backloaded onto the stuck device to aid in its retrieval, the 3max may become damage and resistance may be experienced.Forcefully retracting the 3max against resistance may have contributed to additional damage on the returned 3max.Further evaluation revealed a kink on the 3max proximal shaft.This kink is likely a result of attempts to retract the non-penumbra stent retriever through the 3max lumen.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 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 non-penumbra stent retriever, however, then was experiencing difficulty retracting it out of the patient.The physician therefore advanced the 3maxc, with some resistance, over the proximal end of the stent retriever¿s pusher assembly and attempted to retract the stent retriever into the 3maxc.While retracting, the physician felt significant resistance and, consequently, the stent retriever became lodged within the 3maxc.The physician therefore removed the 3maxc with the stent retriever inside.Upon removal, the physician saw that the tip of the 3maxc was mangled.The procedure ended at this point.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7699000
• MDR Text Key: 114409531
• Report Number: 3005168196-2018-01396
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012490
• UDI-Public: 00814548012490
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2021
• Device Catalogue Number: 3MAXC
• Device Lot Number: F81289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR