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

Catalog Number	PSC054-B
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system 5max reperfusion catheter (5max) strain relief was offset approximately 1.0 cm from the hub.The strain relief was unwound by a penumbra investigator and the catheter shaft was observed to be kinked approximately 2.5 cm from the hub.The 5max was fractured approximately 65.0 cm from the hub.There was no visible damage to the packaging hoop.Conclusions: evaluation of the returned device revealed the 5max was kinked under the strain relief and fractured in the proximal shaft.This type of damage typically occurs due to improper handling during preparation.If the 5max is manipulated forcefully at extreme angles during removal from the packaging hoop, damage such as this may occur.There was no visible damage to the packaging hoop.Penumbra catheters are 100% visually evaluated during in-process inspection.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 hospital staff noticed that the penumbra system 5max reperfusion catheter (5max) plastic cover was broken upon removal from the packaging.The broken 5max was found prior to use and was not used for the procedure.The procedure was completed using a new 5max.

• Brand Name: PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5484791
• Report Number: 3005168196-2016-00289
• Device Sequence Number: 326257
• Product Code: NRY
• UDI-Device Identifier: 00814548012742
• UDI-Public: 00814548012742
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K133317
• 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): 02/08/2016

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: 06/30/2018
• Device Catalogue Number: PSC054-B
• Device Lot Number: F64269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2016
• Initial Report FDA Received Date: 03/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1