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

Model Number PNML6F088904M

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2019

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 in the right middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max).During the procedure, 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.

Manufacturer Narrative

Results: the returned neuron max was not damaged.The hva was not damaged.Conclusions: evaluation of the returned neuron max and its hva revealed undamaged devices.During functional testing, the returned hva was flushed through with water and no leaking was observed.The reported complaint was unable to be confirmed.Evaluation of the returned neuron max and its hva revealed undamaged devices.During functional testing, the returned hva was flushed through with water and no leaking was observed.The reported complaint was unable to be confirmed.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9270629
• MDR Text Key: 164808610
• Report Number: 3005168196-2019-02041
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• Combination Product (y/n): Y
• PMA/PMN Number: K111380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: PNML6F088904M
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: F89581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• 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: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR