MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX HI-FLOW KIT; NRY

Catalog Number 3MAXCKIT

Device Problems Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 01/21/2018

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

During preparation for medical procedure, the hospital technician found that the penumbra system 3max reperfusion catheter (3maxc) was kinked in two places upon removal from the packaging of the penumbra system 3max hi-flow kit.The damage to the 3maxc was found prior to use and therefore the 3maxc was not used in the procedure.The procedure was completed using a new 3maxc.

Manufacturer Narrative

Please note that the device in complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that device was unable to be found for return to the manufacturer and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM 3MAX HI-FLOW KIT
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7286225
• MDR Text Key: 100777093
• Report Number: 3005168196-2018-00373
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016757
• UDI-Public: 00814548016757
• 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: 01/01/2005,01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Expiration Date: 04/11/2020
• Device Catalogue Number: 3MAXCKIT
• Device Lot Number: F75578
• 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: 08/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2017
• 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