MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE064KIT
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/02/2018
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 a medical procedure, the physician noticed that a penumbra system ace 64 reperfusion catheter (ace64) was broken in half and unraveled.The damage to the ace64 occurred prior to use, and therefore it was not used in the procedure.The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68).
Additional Manufacturer Narrative
Results: the ace64 was fractured approximately 83.0 cm from the hub and the catheter shaft coil winds were unraveled conclusions: evaluation of the returned device confirmed that the ace64 was fractured.This type of damage typically occurs due to improper handling during removal from the packaging.If the top portion of the packaging tray is not completely removed, prior to removing the ace64 from the bottom tray, damage such as a fracture may occur.Then if the fractured ace64 is furthermore withdrawn from the tray, unraveling of the catheter shaft coil winds may occur.Penumbra catheters are visually inspected during in-process inspection and during quality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
During a medical procedure, the physician noticed that a penumbra system ace 64 reperfusion catheter (ace64) was broken in half and unraveled.The damage to the ace64 occurred prior to use, and therefore it was not used in the procedure.The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68).

• Brand Name: PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7255938
• Report Number: 3005168196-2018-00305
• Device Sequence Number: 1066207
• Product Code: NRY
• UDI-Device Identifier: 00814548016467
• UDI-Public: 00814548016467
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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: Physician
• Device Expiration Date: 05/24/2020
• Device Catalogue Number: 5MAXACE064KIT
• Device Lot Number: F78305
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1