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

Catalog Number	3MAXCKIT
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem 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.
Additional 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
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7286225
• Report Number: 3005168196-2018-00373
• Device Sequence Number: 13909269
• Product Code: NRY
• UDI-Device Identifier: 00814548016757
• UDI-Public: 00814548016757
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Radiologic Technologist
• Device Expiration Date: 04/11/2020
• Device Catalogue Number: 3MAXCKIT
• Device Lot Number: F75578
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005