MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 HI-FLOW KIT; NRY

Catalog Number	5MAXACE068KIT
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the tubing tray was still attached to the rest of the penumbra system ace 68 hi-flow kit packaging.The penumbra system ace 68 reperfusion catheter (ace 68) was fractured approximately 58.0 cm from the hub.Conclusions: evaluation of the returned device revealed that it was fractured.This type of damage may occur if an attempt is made to withdraw the ace 68 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, the penumbra system ace 68 reperfusion catheter (ace 68) kinked upon removal from the packaging of the penumbra system ace 68 hi-flow kit (kit).The ace 68 became kinked prior to use and therefore, was not used for the procedure.The procedure was completed using a new ace 68.

• Brand Name: PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6281611
• Report Number: 3005168196-2017-00118
• Device Sequence Number: 19121330
• Product Code: NRY
• UDI-Device Identifier: 00814548016597
• UDI-Public: 00814548016597
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161640
• 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
• Report Date (Section B): 12/29/2016

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: Health Professional
• Device Expiration Date: 07/28/2019
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F71659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2016
• Initial Report FDA Received Date: 01/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1