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

Model Number	400SMTHXSFT0415
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed that the embolization coil was detached from the pusher assembly and revealed that the pull wire was retracted from the pusher assembly ddt.If the pull wire was retracted form the ddt, the embolization coil will detach from the pusher assembly as its intended.The detached embolization coil was not returned for evaluation.Further evaluation of the device revealed that the pet lock with the proximal end of the pusher assembly and the pull wire were fractured off and not returned for evaluation.This damage was a result of the manual detachment attempted during the procedure.The handle used in the procedure was not returned for evaluation.Due to the returned condition, the root cause of the smart coil failure to detach with a handle could not be determined.Further evaluation also revealed kinks in the pusher assembly.This damage was likely incidental to the complaint and may have occurred during packaging for return to penumbra.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.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the smart coil failure to detach with a handle.This report is associated with mfr report number: 3005168196-2021-01229.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an arteriovenous fistula (avf) via the right occipital vein using a penumbra smart coil (smart coil), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter and non-penumbra coils.During the procedure, the physician placed ten non-penumbra coils into the target location using the microcatheter.Next, the physician 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.Therefore, physician decided to remove the smart coil.Subsequently, while attempting to remove the smart coil, the physician noticed that the smart coil was entwined with the non-penumbra coils that were previously placed.Consequently, the physician was unable to remove the smart coil.Afterwards, the physician manually detached the smart coil.The procedure was completed using other coils and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11930841
• Report Number: 3005168196-2021-01228
• Device Sequence Number: 11603588
• Product Code: HCG
• UDI-Device Identifier: 00814548015842
• UDI-Public: 00814548015842
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2021
• 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: 11/05/2024
• Device Model Number: 400SMTHXSFT0415
• Device Catalogue Number: 400SMTHXSFT0415
• Device Lot Number: F94115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005