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

Model Number	400SMTHXSFT0306
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
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 anterior communicating artery using a penumbra smart coil (smart coil), penumbra smart coil detachment handles (handles), non-penumbra coils, and a non-penumbra microcatheter.It was noted that the patient anatomy was tortuous, calcified, and narrowed.During the procedure, the physician placed two non-penumbra coils into the target location using the microcatheter.The physician then advanced a smart coil into the target location using the microcatheter and attempted to detach it using a handle; however, the smart coil failed to detach after two attempts.Subsequently, the physician attempted to detach the smart coil using a new handle; however, the smart coil failed to detach after two attempts.Consequently, the physician attempted to detach the smart coil using forceps but was unsuccessful.Therefore, the smart coil was removed.The procedure was completed using five other coils 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 intact with its pusher assembly.Evaluation also revealed that the pet lock was separated on the proximal end of the pusher assembly, but not completely retracted.The root cause of this could not be determined.Further evaluation revealed that, during the functional test, the smart coil was unable to be detached using both returned handles and a demonstration handle.Further evaluation also revealed coagulated blood inside the ddt and a kink in the pusher assembly.This damage was incidental to the reported complaint.The coagulated blood inside the ddt likely occurred post-procedure.The kink in the pusher assembly may have occurred during the procedure.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the detachment issue.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12256964
• Report Number: 3005168196-2021-01702
• Device Sequence Number: 4847651
• Product Code: HCG
• UDI-Device Identifier: 00814548015781
• UDI-Public: 00814548015781
• 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): 09/15/2021
• 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: 11/03/2025
• Device Model Number: 400SMTHXSFT0306
• Device Catalogue Number: 400SMTHXSFT0306
• Device Lot Number: F101702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005