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

Catalog Number PNML6F088904M

Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 05/20/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the distal atraumatic tip of the neuron max was damaged.Bends were observed throughout the length of the neuron max.The packaging card and mandrel were not returned and could not be evaluated.Conclusions: evaluation of the returned neuron maxs revealed the distal atraumatic tips were damaged.This type of damage typically occurs due to improper handling during removal from the packaging.If the packaging mandrel become unsecured from the packaging card, it may pin the neuron max distal atraumatic tip between the packaging mandrel and the packaging tube upon retraction.If the neuron max is subsequently retracted while pinned, the distal tip will likely become damaged.Further evaluation revealed bends along the length of the neuron maxs.Based on the return condition, the bends were likely incidental to the complaint and may have occurred during packaging for return to penumbra.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.This report is associated with mfr report numbers: 3005168196-2018-01202.

Event Description

During preparation for a medical procedure, the hospital staff found that the two neuron maxs 6f 088 long sheath (neuron maxs) had slight tears at the distal tip upon removal from the packaging.The damages to the neuron maxs were found prior to use.Therefore, the neuron maxs were not used in the procedure.The procedure was completed using 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: 7612220
• MDR Text Key: 111446719
• Report Number: 3005168196-2018-01201
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• 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: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/09/2021
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: F81361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• 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