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

Catalog Number 3MAXC

Device Problems Break (1069); Material Separation (1562); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

During preparation for a thrombectomy procedure, the physician noticed that the penumbra system 3max reperfusion catheter (3maxc) was broken into two pieces but still attached by a small piece of wire upon removal from packaging.The broken 3maxc was found prior to use and therefore, was not used in the procedure.It is unknown how the procedure was completed.

Manufacturer Narrative

The penumbra system 3max reperfusion catheter (3maxc) was fractured approximately 7.5 cm from the proximal hub.Evaluation of the returned 3maxc confirmed that the catheter was fractured near its proximal hub.This type of damage can occur if the catheter is forcefully retracted from its packaging hoop at extreme angles.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.

• 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: 6699279
• MDR Text Key: 79836491
• Report Number: 3005168196-2017-01132
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012490
• UDI-Public: 00814548012490
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/07/2020
• Device Catalogue Number: 3MAXC
• Device Lot Number: F74831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2017
• 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