MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER; NRY

Catalog Number 5MAXACE132

Device Problems Device Damaged Prior to Use (2284); Deformation Due to Compressive Stress (2889)

Patient Problem No Patient Involvement (2645)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2018-01532.

Event Description

During preparation for a medical procedure, a penumbra system ace 60 reperfusion catheter (ace60) and a neuron max 6f 088 long sheath (neuron max) were each found kinked at the proximal shaft upon removal from the packaging.The damage to the ace60 and neuron max were found prior to use therefore, they were not used in the procedure.The procedure was completed using a new ace60 and neuron max.

Manufacturer Narrative

Results: the returned ace60 was kinked approximately 22.0 cm from the hub.Conclusions: evaluation of the returned ace60 confirmed a device with a kink on the proximal end.If the device is forcefully removed from the packaging at extreme angles, damage such as a kink may occur.Evaluation of the returned neuron max revealed a damaged distal atraumatic tip.This type of damage typically occurs during removal of the device from its packaging.If the packaging mandrel becomes unsecured from the packaging card, it may pin the neuron max distal atraumatic tip between the mandrel and the packaging tube.If the device is subsequently retracted while pinned, the distal atraumatic tip will likely become damaged.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.This report is associated with mfr report number: 1.3005168196-2018-01532.

• Brand Name: PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7754637
• MDR Text Key: 116227321
• Report Number: 3005168196-2018-01531
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548017426
• UDI-Public: 00814548017426
• Combination Product (y/n): Y
• PMA/PMN Number: K160449
• 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: 01/01/2005,07/11/2018

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: 10/08/2020
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: C05684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• 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