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

Catalog Number PNML6F088904

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 using a neuron max 6f 088 long sheath (neuron max), the physician found that the hemostasis valve adaptor (hva) was leaking and was not tightening properly; therefore, it was removed.The procedure was completed using another neuron max.There was no report of an adverse effect to the patient.

• 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: 8206990
• MDR Text Key: 131774589
• Report Number: 3005168196-2018-02544
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012179
• UDI-Public: 00814548012179
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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
• Report Date: 01/01/2005,12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2021
• Device Catalogue Number: PNML6F088904
• Device Lot Number: F83542
• Was Device Available for Evaluation?: No
• 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: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1