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

Model Number 400SMTSFT0510

Device Problem Separation Failure (2547)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

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.This report is associated with mfr report numbers: 3005168196-2021-00416, 3005168196-2021-00417.

Event Description

The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician was unable to advance a smart coil past its initial position within its introducer sheath; therefore, the smart coil was removed.Next, the same issue occurred with another smart coil and subsequently, the physician kinked the pusher wire.Therefore, this smart coil was also removed.While attempting to detach the next smart coil using the handle, it was reported that the smart coil would not detach.Although the click of the handle was audible and the smart coil appeared to detach, the coil did not detach.The physician made five attempts to detach the smart coil using the handle before manually detaching the smart coil.The procedure was completed using additional smart coils, the same handle, and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the first returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the kink observed near the mid-joint.During functional testing, strong resistance was experienced while attempting to advance the smart coil from its returned position within the introducer sheath and the smart coil could not advance at all.Evaluation of the second returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the kink and fracture observed near the mid-joint.Further evaluation revealed a detached embolization coil.This damage was likely a result of the pusher assembly fracture.Evaluation of the third returned smart coil revealed that the pet lock was separated on the proximal end of the pusher assembly and the embolization coil was detached.No functional testing could be performed; therefore, the root cause of the detachment issue during the procedure could not be determined.Further evaluation revealed a pusher assembly kink.This damage was likely incidental to the reported complaint.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of detachment issue.This report is associated with mfr report numbers: 1.3005168196-2021-00416, 2.3005168196-2021-00417.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11425196
• MDR Text Key: 244220923
• Report Number: 3005168196-2021-00418
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015101
• UDI-Public: 00814548015101
• Combination Product (y/n): Y
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400SMTSFT0510
• Device Catalogue Number: 400SMTSFT0510
• Device Lot Number: F98291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• 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: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR