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

Catalog Number	PSC054
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	03/03/2018
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 hospital staff found that the penumbra system 5max reperfusion catheter (5maxc) was broken approximately 40cm from the proximal hub upon removal from the packaging.The damage to the 5maxc was found prior to use and therefore, it was not used in the procedure.The procedure was completed using a new 5maxc.
Additional Manufacturer Narrative
Results: the 5maxc was fractured approximately 82.0 cm from the hub.Conclusions: evaluation of the returned 5maxc revealed a fractured device.If the 5maxc is forcefully removed from the packaging hoop at extreme angles or otherwise mishandled during preparation, damage such as a kink may occur.If a kink is further manipulated or mishandled, the kink may become fractured.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 5MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7399592
• Report Number: 3005168196-2018-00710
• Device Sequence Number: 19137832
• Product Code: NRY
• UDI-Device Identifier: 00814548012742
• UDI-Public: 00814548012742
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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: 12/27/2020
• Device Catalogue Number: PSC054
• Device Lot Number: F81203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1