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	07/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the 5max ace was kinked approximately 62.0 cm from the hub.Conclusions: evaluation of the returned device confirmed that the 5max ace was kinked.This type of damage typically occurs due to improper handling during removal from the packaging.If the device is forcefully retracted at an angle from its packaging hoop during removal, damage such as this may occur.Penumbra catheters are visually 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
While preparing a penumbra system 5max ace reperfusion catheter (5max ace) for a thrombectomy procedure, the physician opened the 5max ace packaging and flushed the packaging hoop and 5max ace.Upon removing the 5max ace from its dispenser hoop after the flush, the physician confirmed a kink approximately 60 cm from the proximal end of the 5max ace.The damaged 5max ace was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new 5max ace.

• 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: 6764695
• Report Number: 3005168196-2017-01345
• Device Sequence Number: 2064553
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2017

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: 02/22/2020
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F74549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1