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

Model Number	400SMTSFT0406
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, six smart coils were implanted into the target location using the handle.The physician attempted to detach the next smart coil using the handle but was unable to do so; manual detachment also failed.Therefore, the smart coil was removed.The procedure was completed using another smart coil, the same handle, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed that the embolization coil was unable to be detached.Further evaluation revealed that the pet lock was missing from the proximal end of the pusher assembly, the pull wire was in its original position on the proximal end of the pusher assembly and inside the ddt, and the embolization coil was intact with the pusher assembly.The missing pet lock likely occurred during the attempt to detach the embolization coil from the pusher assembly with a handle and manually.Based on the reported complaint, the patient anatomy was tortuous.This may have contributed to resistance within the pusher assembly and prevented the pull wire from being retracted from the ddt.Further evaluation revealed a kink in the pusher assembly, coagulated blood inside the ddt, and offset coil winds throughout the length of the embolization coil.This damage was incidental to the reported complaint and the root cause could not be determined.During the functional test, the smart coil was unable to detached using a demonstration handle or manual detachment.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
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12319549
• Report Number: 3005168196-2021-01809
• Device Sequence Number: 14496464
• Product Code: HCG
• UDI-Device Identifier: 00814548015071
• UDI-Public: 00814548015071
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2021
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/08/2022
• Device Model Number: 400SMTSFT0406
• Device Catalogue Number: 400SMTSFT0406
• Device Lot Number: F73571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 53
• Date Report Sent to FDA: 01/01/2005