MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Model Number 400SMTHXSFT1H04

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-02635.

Event Description

The patient was undergoing a coil embolization procedure in the lumbar artery using a penumbra smart coil (smart coil), a penumbra smart coil detachment handle (handle), non-penumbra coils, and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician successfully implanted six coils in the target location.After advancing a smart coil into the target location, the handle failed to detach the smart coil after three attempts.The physician also attempted to detach the smart coil manually by hand and by cutting the pusher assembly using pean forceps, but was unsuccessful.The physician then decided to remove the smart coil.After removal of the pusher assembly of the smart coil from the hub of the microcatheter, the physician noticed that the smart coil had detached around the hub of the microcatheter.Therefore, the smart coil was removed from the microcatheter.The procedure was completed at this point since the aneurysm was sufficiently packed.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned smart coil confirmed, that the embolization coil was detached from the pusher assembly.Evaluation revealed, that the pusher assembly was fractured and kinked at its proximal end.The pet lock was not present on the pusher assembly, and the pull wire was retracted from the pusher assembly distal detachment tip (ddt).These damages likely occurred, due to the manual coil detachment attempted, during the procedure.The detached embolization coil was not returned for evaluation.Based on the returned condition, the smart coil was unable to be functionally tested.And the root cause of the reported complaint could not be determined.Penumbra coils 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.This report is associated with mfr report number: 1.13005168196-2021-02635.H3 other text: placeholder.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• 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: 12847544
• MDR Text Key: 285389308
• Report Number: 3005168196-2021-02634
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015675
• UDI-Public: 00814548015675
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400SMTHXSFT1H04
• Device Catalogue Number: 400SMTHXSFT1H04
• Device Lot Number: F94278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• 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: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2019
• 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