MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

Catalog Number PNML6F088904

Device Problems Kinked (1339); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the neuron max 6f 088 long sheath (neuron max) was kinked approximately 23.0 and 31.0 cm from the hub.Conclusions: evaluation of the returned devices revealed the ace 60 was fractured and the neuron max was kinked.These damages may have occurred due to forceful handling during removal from the packaging.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: 3005168196-2016-01838.

Event Description

During preparation for a thrombectomy procedure, the technologist inadvertently kinked the penumbra system ace 60 reperfusion catheter (ace 60) and the neuron max 6f 088 long sheath (neuron max) upon removal from their packaging.The ace 60 and neuron max became kinked prior to use and therefore, were not used for the procedure.The procedure was successfully completed using a new ace 60 and a new neuron max.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6191896
• MDR Text Key: 62912240
• Report Number: 3005168196-2016-01839
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012179
• UDI-Public: 00814548012179
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Expiration Date: 06/29/2019
• Device Catalogue Number: PNML6F088904
• Device Lot Number: F70373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1