MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 60 HI-FLOW KIT; NRY

Catalog Number	5MAXACE132KIT
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	06/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the 5max ace was kinked approximately 59.0 cm from the hub.Conclusions: evaluation of the returned device revealed the 5max ace was kinked approximately 59.0 cm from the hub.This type and locations of damage typically occurs if the 5max ace is withdrawn from the packaging shell prior to removing the tubing tray.Penumbra catheters are inspected during in-process inspection and during quality inspection after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 or Problem Description
During preparation for a thrombectomy procedure, a penumbra system 5max ace reperfusion catheter (5max ace) was kinked at the hub upon removal from the packaging tray.The damage to the 5max ace occurred prior to use; therefore, it was not used in the procedure.The procedure was completed using a new 5max ace.
Additional Manufacturer Narrative
Correction: corrected ¿brand name¿ from penumbra system 5max ace reperfusion catheter to penumbra system ace 60 hi-flow kit.
Additional Manufacturer Narrative
Corrected from penumbra system 5max ace reperfusion catheter to penumbra system ace 60 hi-flow kit.Results: the ace60 was kinked approximately 59.0 cm from the hub.Conclusions: evaluation of the returned device revealed the ace60 was kinked approximately 59.0 cm from the hub.This type and locations of damage typically occurs if the ace60 is withdrawn from the packaging shell prior to removing the tubing tray.Penumbra catheters are inspected during in-process inspection and during quality inspection after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 or Problem Description
During preparation for a thrombectomy procedure, a penumbra system ace 60 hi-flow kit (ace60) was kinked at the hub upon removal from the packaging tray.The damage to the ace60 occurred prior to use; therefore, it was not used in the procedure.The procedure was completed using a new ace60.

• Brand Name: PENUMBRA SYSTEM ACE 60 HI-FLOW KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6719963
• Report Number: 3005168196-2017-01210
• Device Sequence Number: 16393545
• Product Code: NRY
• UDI-Device Identifier: 00814548017433
• UDI-Public: 00814548017433
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 06/20/2017
• 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: Physician
• Device Expiration Date: 02/25/2019
• Device Catalogue Number: 5MAXACE132KIT
• Device Lot Number: F68121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 06/20/2017; 01/14/2005
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 08/15/2017; 09/26/2018
• 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