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

Model Number 400SMTXSFT0204

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 03/14/2022

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the internal carotid artery using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician successfully implanted one smart coil in the aneurysm using the handle.The physician then advanced another smart coil into the aneurysm and attempted to detach it using the handle; however, the smart coil failed to detach after multiple attempts.Subsequently, the physician manually detached the smart coil by breaking the pusher assembly of the coil.It was reported that the physician had difficulty manually detaching the smart coil, and upon detachment, the microcatheter was no longer in the aneurysm.Consequently, a portion of the smart coil prolapsed into the parent vessel.The procedure ended at this point.The physician then administered blood thinners to the patient to prevent thrombosis.On the following day, the physician implanted a stent to stabilize the previously prolapsed smart coil up against the vessel wall.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 its pusher assembly.Evaluation revealed that the pet lock was fractured off the proximal end of the pusher assembly, and the pull wire was retracted from the pusher assembly ddt.This damage likely occurred due to the manual detachment attempted during the procedure.The detached embolization coil was not returned for evaluation.The root cause of the difficulty experienced detaching the smart coil could not be determined.Penumbra products are visually 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.The investigation findings do not lead to a clear conclusion about the root cause of the reported detachment issue.

• 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: 14031811
• MDR Text Key: 288809000
• Report Number: 3005168196-2022-00159
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015286
• UDI-Public: 00814548015286
• 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: 01/01/2005,04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400SMTXSFT0204
• Device Catalogue Number: 400SMTXSFT0204
• Device Lot Number: F107140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• 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: 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2021
• 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: 50 YR
• Patient Sex: Female