MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 64 HI-FLOW KIT; NRY

Catalog Number	5MAXACE064KIT
Medical Device Problem Codes	Stretched (1601); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 technician opened the packaging of the penumbra system ace 64 hi-flow kit (kit) and then the physician removed the penumbra system ace 64 reperfusion catheter (ace64) from the packaging.Upon removal from the packaging, the physician noticed that the ace64 was stretched at the mid shaft and that the inner coil could be seen.The damaged ace64 was found prior to use and therefore, was not used for the procedure.The procedure was completed using a non-penumbra balloon catheter and stent retriever device.
Additional Manufacturer Narrative
The penumbra system ace 64 reperfusion catheter (ace64) was fractured approximately 61.0 cm from the hub.Evaluation of the returned device revealed that the ace64 was fractured.This type of damage typically occurs if an attempt to withdraw the ace64 from the kit packaging is made prior to removing the tubing tray.Penumbra catheters are 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 ACE 64 HI-FLOW KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7021184
• Report Number: 3005168196-2017-01966
• Device Sequence Number: 956238
• Product Code: NRY
• UDI-Device Identifier: 00814548016467
• UDI-Public: 00814548016467
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2017

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: 08/26/2019
• Device Catalogue Number: 5MAXACE064KIT
• Device Lot Number: F71307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1