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

Catalog Number PNML6F088904M

Device Problems Device Damaged Prior to Use (2284); Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the returned neuron max was damaged at the distal tip.The packaging mandrel was loose within the product pouch.Conclusions: evaluation of the returned revealed that the catheter was damaged at the tip.If the packaging mandrel becomes unsecured from the packaging tape during retraction of the catheter it may interact with the packaging tube.The distal tip of the neuron max may become pinned between the packaging mandrel and packaging tube.If the catheter is subsequently retracted while pinned, the tip may become damaged.Further evaluation revealed the catheter was bent along its length.Based on the returned condition, this damage was likely incidental to the reported failure and 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.

Event Description

During preparation for a medical procedure, the physician was unable to remove the mandrel from the tip of a neuron max 6f 088 long sheath (neuron max) and, therefore, the neuron max was 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: 7986477
• MDR Text Key: 124514589
• Report Number: 3005168196-2018-02086
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2020
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: F78141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Is the Reporter a Health Professional?: Yes
• 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: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1