MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 60 HI-FLOW KIT; NRY

Catalog Number 5MAXACE132KIT

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

During preparation for a thrombectomy procedure, the hospital found that the penumbra system ace 60 reperfusion catheter (ace60) could not be flushed in a proper way for unknown reasons.The reported issue was found prior to use.Therefore, the ace60 was not used in the procedure.The procedure was completed using a new ace60.

Manufacturer Narrative

Results: there was no visible damage to the ace60.The distal tip of the ace60 had coagulated blood inside.Conclusions: evaluation of the returned ace60 revealed no visible damage.During decontamination and functional test, the ace60 was flushed using the decontamination solution and water without issue.Further evaluation of the returned ace60 revealed that the distal tip of the catheter had coagulated blood inside.The coagulated blood likely contributed to the inability to flush the ace60 during the procedure.Although the complaint stated that the device was not used in the procedure, blood occluded the tip of the returned device.This indicates the ace60 was likely used in the procedure.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 ACE 60 HI-FLOW KIT
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7754441
• MDR Text Key: 116227645
• Report Number: 3005168196-2018-01526
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548017433
• UDI-Public: 00814548017433
• Combination Product (y/n): Y
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2021
• Device Catalogue Number: 5MAXACE132KIT
• Device Lot Number: F81859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1