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

Catalog Number	5MAXACE068KIT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system ace 68 reperfusion catheter (ace 68) was kinked approximately 56.0 cm from the hub.Conclusions: evaluation of the returned devices revealed that the ace 68 was kinked.The location and type of damage on the ace 68 typically occurs when the tubing tray is not removed prior to withdrawing the ace 68 from the packaging shell.Further evaluation revealed that the 3max was fractured.This damage may have occurred due to forceful advancement of the 3max through the damaged ace 68.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.This report is associated with mfr report number: 1.3005168196-2017-00427.
Event or Problem Description
The patient was undergoing thrombectomy procedure using a penumbra system 3max reperfusion catheter (3max) and a penumbra system ace 68 hi-flow kit (kit).During the procedure, while attempting to advance the 3max into the penumbra system ace 68 reperfusion catheter (ace 68), the physician did not mention feeling any resistance; however, the 3max broke into two pieces.Therefore, the devices were removed and the procedure was completed using a new 3max and a new kit.It should be noted that there were no reported damages to the ace 68.Additionally, there was no report of an adverse effect to the patient.

• 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: 6424726
• Report Number: 3005168196-2017-00428
• Device Sequence Number: 537164
• Product Code: NRY
• UDI-Device Identifier: 00814548016597
• UDI-Public: 00814548016597
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2017

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: 06/08/2019
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F71727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2017
• Initial Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR