MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER; NRY

Catalog Number	4MAXC
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	08/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
During preparation for a thrombectomy procedure, the physician noticed that the distal tip of the penumbra system 4max reperfusion catheter (4max) was kinked upon removal from its dispenser hoop.The kinked 4max was found prior to use and therefore, was not used for the procedure.The procedure was completed using a new 4max.
Additional Manufacturer Narrative
Please note that pma/510(k)# has been updated to reflect the most current 510(k) # for the device at the time of the reported complaint.Results: the penumbra system 4max reperfusion catheter (4max) was kinked approximately 40.0 cm from the hub.There was no visible damage to the distal tip of the 4max.Conclusions: evaluation of the returned device revealed that the 4max was kinked.This type of damage typically occurs due to improper handling during preparation.If the device is forcefully handled during removal from the packaging hoop or preparation for use, damage such as this may occur.There was no visible damage to the distal tip of the 4max.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.

• Brand Name: PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6090699
• Report Number: 3005168196-2016-01576
• Device Sequence Number: 19281847
• Product Code: NRY
• UDI-Device Identifier: 00814548012414
• UDI-Public: 00814548012414
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 10/11/2016

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: Physician
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 4MAXC
• Device Lot Number: F64729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2016
• Supplement Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1