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

Catalog Number 3MAXC

Device Problems Device Damaged Prior to Use (2284); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.This report is associated with mfr report numbers: 3005168196-2019-00079; 3005168196-2019-00081; 3005168196-2019-00082; 3005168196-2019-00083; 3005168196-2019-00088.

Event Description

The patient was undergoing a thrombectomy procedure in the basilar artery using penumbra system 3max reperfusion catheters (3maxcs), a penumbra system jetd reperfusion catheter (jetd), a velocity delivery microcatheter (velocity), penumbra system 3d revascularization device (3d) and a neuron max 6f 088 long sheath (neuron max).It should be noted that the patient¿s anatomy was tortuous, and the physician decided to take a radial approach.During preparation for the procedure, the first 3maxc became bent on the back table and was not used in the procedure.A second 3maxc was then advanced through a neuron max followed by a 3d; however, the 3d was unable to advance through the 3maxc beyond the v3 segment.Therefore, the 3d and the 3maxc were removed from the vessel and set aside.The physician then advanced the velocity through a jetd into the basilar artery using the same neuron max; however, the velocity was unable to advance to the target location.The velocity and jetd were therefore removed from the patient¿s vessel.During the next angiogram, the physician identified a radiopaque marker inside the patient¿s mid basilar artery.It was then noted that the second 3maxc used had fractured and remained in the patients vessel.The physician then attempted to advance a guidewire to the basilar artery to continue the procedure but was unable to advance it further.The guidewire was therefore removed.The physician then decided to end the procedure.However, the physician experienced difficultly removing the neuron max as the patient began having vasospasms.Upon removal of the neuron max, the procedure ended and the basilar artery remained occluded.It was reported that the patient passed away a few days later on (b)(6) 2018.It was also reported that the cause of death was respiratory arrest; however, the relationship between the fractured 3maxc tip and the cause of death is currently unknown.

• 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: 8242969
• MDR Text Key: 132916765
• Report Number: 3005168196-2019-00080
• Device Sequence Number: 1
• Product Code: NRY
• 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
• Report Date: 01/01/2005,12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3MAXC
• Was Device Available for Evaluation?: No
• 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: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 84 YR