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

Model Number 400SMTSFT3H08

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure in the right middle cerebral artery (mca) using penumbra smart coils (smart coil) and non-penumbra microcatheter.During the procedure, the physician placed eight smart coils in the target vessel using the microcatheter.While advancing another smart coil, the physician experienced resistance after advancing the smart coil halfway into the aneurysm and the coil started snaking within the microcatheter.Therefore, the smart coil was removed.The procedure was completed using a new smart coil and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned smart coil revealed that the embolization coil had offset coil winds along its length.If the device is advanced against resistance, damage such as offset coil winds may occur.Further evaluation of the device revealed that the pusher assembly was kinked throughout its length, the embolization coil was partially advanced out of the introducer sheath and had a knot.This damage was likely incidental to the complaint.Due to the knot and the offset coil winds in the embolization coil, the smart coil was unable to be advanced or retracted from its returned position, and therefore, functional testing could not be performed.The root cause of the reported resistance during the procedure could not be determined.Penumbra coils 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.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11098312
• MDR Text Key: 226041146
• Report Number: 3005168196-2020-02387
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017013
• UDI-Public: 00814548017013
• 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: 01/01/2005,12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400SMTSFT3H08
• Device Catalogue Number: 400SMTSFT3H08
• Device Lot Number: F94237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• 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: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR