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

Catalog Number 3MAXC

Device Problems Fracture (1260); Physical Resistance (2578); Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system 3max reperfusion catheter (3max) was fractured approximately 141.0 cm from the hub.Conclusions: evaluation of the device revealed a fracture on the distal region of the catheter shaft.This type of damage may result from retracting the catheter against strong resistance.The excessively calcified clot may have pinned the catheter inside the anatomy resulting in the resistance felt by the physician when retracting the catheter and ultimately the 3max fracture.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 to treat a cardiogenic cerebral infarction in the m1 segment of the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3max).During the procedure, the physician coaxially advanced a penumbra system 5max ace reperfusion catheter (5max ace) and the 3max through a balloon guiding catheter to the target vessel.After successfully completing the first pass using the adapt technique, the 3max was removed.While attempting to re-insert the 3max into the 5max ace, the physician noticed that the 3max was fractured at the mid-shaft.The physician believes that the 3maxc was damaged when advancing it forcefully around the internal carotid artery (ica), which was confirmed to have excessive calcification.In addition, the physician experienced a slight resistance when retracting the 3max and the physician believed that it is possible that the fracture might have occurred during the removal process.The 3max was set aside and the procedure was completed using a new 3max and the same 5max ace.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: 6439853
• MDR Text Key: 71052986
• Report Number: 3005168196-2017-00468
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012490
• UDI-Public: 00814548012490
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/15/2019
• Device Catalogue Number: 3MAXC
• Device Lot Number: F71103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2016
• 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: 73 YR