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

Catalog Number 3MAXC

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system 3max reperfusion catheter (3max) was fractured approximately 78.0 cm from the hub.Conclusions: evaluation of the returned devices revealed that the ace 68 was kinked.The location and type of damage on the ace 68 typically occurs when the tubing tray is not removed prior to withdrawing the ace 68 from the packaging shell.Further evaluation revealed that the 3max was fractured.This damage may have occurred due to forceful advancement of the 3max through the damaged ace 68.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.This report is associated with mfr report number: 3005168196-2017-00428.

Event Description

The patient was undergoing thrombectomy procedure using a penumbra system 3max reperfusion catheter (3max) and a penumbra system ace 68 hi-flow kit (kit).During the procedure, while attempting to advance the 3max into the penumbra system ace 68 reperfusion catheter (ace 68), the physician did not mention feeling any resistance; however, the 3max broke into two pieces.Therefore, the devices were removed and the procedure was completed using a new 3max and a new kit.It should be noted that there were no reported damages to the ace 68.Additionally, 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: 6424645
• MDR Text Key: 70632812
• Report Number: 3005168196-2017-00427
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012490
• UDI-Public: 00814548012490
• Combination Product (y/n): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/07/2019
• Device Catalogue Number: 3MAXC
• Device Lot Number: F72664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2016
• 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: 71 YR