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

Catalog Number 400SMTHXSFT0102

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 08/18/2022

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the distal a2 segment of the anterior cerebral artery (aca) using penumbra smart coils (smart coil) and a penumbra smart coil detachment handle (handle).During the procedure, the physician advanced a smart coil as the first coil to the target vessel and attempted to detach it using the handle; however, the smart coil failed to detach.Subsequently, the physician manually detached the smart coil using hemostats after multiple attempts.Then, the physician advanced another smart coil to the target vessel and attempted to detach it using the handle; however, the same issue occurred.Subsequently, the physician also manually detached the smart coil using hemostats after multiple attempts.It was also reported that the smart coil almost came out of the aneurysm after detachment after pulling on the pusher assembly of the coil to manually detach it; however, the physician was able to carefully place the smart coil back into the aneurysm by pushing it into the aneurysm using the microcatheter.The procedure was completed using other coils.There was no report of an adverse effect to the patient.

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.

• 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: 15415640
• MDR Text Key: 305287938
• Report Number: 3005168196-2022-00429
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015613
• UDI-Public: 814548015613
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400SMTHXSFT0102
• Device Lot Number: F110791
• 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: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• 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: 28 YR
• Patient Sex: Male