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

Catalog Number PNML6F088904M

Device Problems Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2017

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

The patient was undergoing a medical procedure using a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician was unable to advance the neuron max into the patient¿s body, despite using a non-penumbra 8f groin sheath.The procedure was therefore completed using a new neuron max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: there was no visible damage to the neuron max 6f 088 long sheath (neuron max) or the dilator.Conclusions: evaluation of the returned devices revealed no visible damage to the neuron max or the dilator.The root cause of the reported issue could not be determined.The neuron max was unable to be functionally tested for the reported issue.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.

• 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: 7179324
• MDR Text Key: 97736186
• Report Number: 3005168196-2018-00102
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/05/2020
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: F74772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2017
• 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
• Patient Age: 59 YR