MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F SELECT CATHETER; DQY

Catalog Number PNS6F105BER

Device Problems Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a diagnostic procedure using a neuron 6f select catheter (6f select).During the procedure, while attempting to advance the 6f select through a neuron max 6f 088 long sheath (neuron max), the physician experienced resistance after advancing the 6f select approximately twenty centimeters into the neuron max.Therefore, the 6f select was removed and the procedure was successfully completed using a new neuron 5f select catheter (5f select) and the same neuron max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the neuron 6f select catheter (6f select) was slightly deformed along its length.The go ring gauge was able to be passed over the 6f select's joint within specification.Conclusions: evaluation of the returned 6f select revealed that it was able to advance through a demonstration neuron max with some resistance.Although the returned unit was within specification, it did not track smoothly through the demonstration neuron max (compatible parent device).It is possible that advancing the returned 6f select against resistance repeatedly could have worsened the deformation and caused increased resistance.Further evaluation revealed that the catheter shaft was slightly deformed along its length.This damage was likely a result of the tightly wound return condition.The neuron max referred to in the complaint was not returned for evaluation and, therefore, the root cause of the initial resistance could not be determined.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.

• Brand Name: NEURON 6F SELECT CATHETER
• 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: 7153320
• MDR Text Key: 96226592
• Report Number: 3005168196-2017-02315
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012131
• UDI-Public: 00814548012131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/08/2020
• Device Catalogue Number: PNS6F105BER
• Device Lot Number: F76969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2017
• 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: 9 YR
• Patient Weight: 45