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

Catalog Number PNML6F088904

Device Problem Partial Blockage (1065)

Patient Problem No Patient Involvement (2645)

Event Date 03/09/2014

Event Type  malfunction  

Event Description

During preparation for a procedure using a neuron max 6f 088, the physician attempted to insert a terumo 0.35" wire; however, the neuron max was reportedly "blocked" and could not go through.The device was not used in the patient.

Manufacturer Narrative

Result: there is no visual damage to the neuron max 088 exterior extrusion.The catheter appears to be in good condition.A 0.088" mandrel was introduced through the hub of the neuron max 088 long sheath and advanced distally through the entire lumen of the catheter to the distal tip without issue.The catheter is functional.Conclusion: the device was returned for analysis and has been evaluated.The compliant indicates that the neuron max 088 long sheath was blocked and a terumo 0.035" wire would not pass through.Evaluation of the returned device revealed no visual or functional damage.The catheter is fully functional without any sign of a defect.The cause of this complaint cannot be determined.These devices are 100% visual inspected for damage during packaging.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.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 3731850
• MDR Text Key: 4323345
• Report Number: 3005168196-2014-00202
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: PNML6F088904
• Device Lot Number: F40239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2013
• 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