MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER; NRY

Catalog Number 5MAXACE068

Device Problems Break (1069); Fluid/Blood Leak (1250); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 10/26/2018

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 staff removed a penumbra system ace 68 reperfusion catheter (ace68) from its packaging and flushed it with saline; however, it was noticed that the ace68 was leaking due to a fracture.The physician reported that the ace68 was fractured before the device was removed from the packaging.The damaged ace68 was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new ace68.

Manufacturer Narrative

Results: the 5max ace was fractured approximately 32.5 cm from the hub.The device was kinked approximately 67.0 cm from the hub.Conclusions: evaluation of the returned 5max confirmed a fracture.If the device is forcefully mishandled at extreme angles during removal from the packaging hoop, the device may become fractured.Further evaluation revealed a kink along the 5max which was likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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 68 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8117390
• MDR Text Key: 128915945
• Report Number: 3005168196-2018-02336
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016535
• UDI-Public: 00814548016535
• Combination Product (y/n): Y
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/31/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2021
• Device Catalogue Number: 5MAXACE068
• Device Lot Number: F84009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 03/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1