MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE132
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	05/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
While preparing a penumbra system 5max ace reperfusion catheter (5max ace) for the thrombectomy procedure, the physician opened the package and flushed the 5max ace through its hoop with saline.Upon removal from the packaging hoop, the physician confirmed that the 5max ace was kinked at the shaft, approximately one centimeter from the hub.The kinked 5max ace was found prior to its use and therefore, was not used in the procedure.The procedure was completed using a new 5max ace without further issues.
Additional Manufacturer Narrative
Results: the penumbra system 5max ace reperfusion catheter (5max ace) was kinked approximately 2.0 cm from the hub.Conclusions: evaluation of the returned device confirmed it was kinked.This damage may have occurred due to forceful handling of the 5max ace at extreme angles during removal from the packaging hoop.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.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6663228
• Report Number: 3005168196-2017-00972
• Device Sequence Number: 19036696
• Product Code: NRY
• UDI-Device Identifier: 00814548012803
• UDI-Public: 00814548012803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2017

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: 02/01/2020
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F74115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 06/27/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1