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

Model Number	400SMTHXSFT0202
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
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.This report is associated with mfr report number: 3005168196-2021-01658.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid-posterior communicating artery (icpc) using a penumbra smart coil (smart coil), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician placed four coils into the target location using the microcatheter.Next, the physician advanced a smart coil into the target location using the microcatheter and detach it using a handle.While the physician attempted to remove the pusher assembly of the smart coil from the microcatheter, the physician noticed that the smart coil was still connected to its pusher assembly.Subsequently, it was noticed that approximately two centimeters of the proximal end of the smart coil was in the microcatheter and the distal end was in the aneurysm.The physician then pulled gently on the pusher assembly after thinking that the smart coil might have been detached already; however, the smart coil also moved back.Consequently, it was noticed that most of the smart coil was already in the microcatheter.On retrieval, it was noticed that the smart coil had become detached in the microcatheter.Therefore, the microcatheter containing the detached smart coil was removed.Afterwards, an angiography confirmed blood flow was stopped successfully.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the pet lock was separated, and the embolization coil was detached form the pusher assembly.If the pet lock is separated and the pull wire is retracted out of the ddt during a successful detachment using the handle, the embolization coil will detach from the pusher assembly.Further evaluation of the device revealed a damage braided shaft in the pusher assembly and offset coil winds on the embolization coil.This damage was likely incidental to the complaint.Evaluation of the returned handle revealed a functional and undamaged device.During functional testing, the handle was tested with a handle test fixture and performed within specification.Penumbra coils and handles are visually inspected and functionally tested during incoming inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2021-01658 h3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12222338
• Report Number: 3005168196-2021-01657
• Device Sequence Number: 17134336
• Product Code: HCG
• UDI-Device Identifier: 00814548015699
• UDI-Public: 00814548015699
• 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): 08/19/2021
• 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: 07/01/2023
• Device Model Number: 400SMTHXSFT0202
• Device Catalogue Number: 400SMTHXSFT0202
• Device Lot Number: F84410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Date Report Sent to FDA: 01/01/2005