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

Model Number	400SMTSFT3H06
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2021-02213, 3005168196-2021-02214, 3005168196-2021-02216, 3005168196-2021-02217.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle) and a non-penumbra microcatheter.During the procedure, the physician placed two non-penumbra coils and two smart coils into the target location using the microcatheter.The physician then advanced another smart coil (400smtsft3h06) into the target vessel using the microcatheter and attempted to detach it using the handle (f103332); however, the smart coil failed to detach.The physician attempted to manually detach the smart coil, but the smart coil did not detach.Subsequently, the physician also attempted to detach the smart coil using forceps but was unsuccessful.Therefore, the smart coil was removed.Afterwards, the physician advanced another smart coil (400smtsft3h06) into the target vessel using the microcatheter and attempted to detach it using the same handle (f103332); however, the smart coil failed to detach.Therefore, the smart coil was also removed.The physician then placed three non-penumbra coils and four smart coils into the target location using a new handle (f96975).Next, the physician advanced another smart coil (400smtsft0510) into the target vessel using the microcatheter and attempted to detach it using the second handle; however, the smart coil failed to detach.Therefore, the smart coil was removed.The procedure was completed using four smart coils that were manually detached and twelve non-penumbra coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned smart coil confirmed, that the pet lock was separated on the proximal end of the pusher assembly, and the embolization coil was intact with offset coil winds.Further evaluation revealed, that the pusher assembly braided shaft was delaminated along the distal shaft.The cause of this damage could not be determined.This damage may have contributed to the inability to detach the embolization coil, during the procedure and the functional test.Evaluation of the first returned handle could not confirm, the reported complaint.Evaluation revealed, an undamaged functional device.The nose cone was removed from the handle body and was measured with pin gauges to be within specification.The handle was tested on a handle test fixture and performed within specification.The handle was used to detach a demonstration smart coil without an issue.Evaluation of the second returned smart coil confirmed, that the pet lock was separated on the proximal end of the pusher assembly, and the embolization coil was intact.And had offset coil winds.Further evaluation revealed, that the pusher assembly braided shaft was delaminated along the distal shaft.The cause of this damage could not be determined.This damage may have contributed to the inability to detach the embolization coil, during the procedure and the functional test.Evaluation of the third returned smart coil confirmed, that the pet lock was separated on the proximal end of the pusher assembly, and the embolization coil was intact.And had offset coil winds.Further evaluation revealed, that the pusher assembly braided shaft was delaminated along the distal shaft.The cause of this damage could not be determined.This damage may have contributed to the inability to detach the embolization coil, during the procedure and the functional test.Evaluation of the second returned handle could not confirm, the reported complaint.Evaluation revealed, an undamaged functional device.The nose cone was removed from the handle body and was measured with pin gauges to be within specification.The handle was tested on a handle test fixture and performed within specification.The handle was used to detach a demonstration smart coil without an issue.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are 100% visually inspected and functionally tested, during incoming quality inspection.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 inability to detach the embolization coil.This report is associated with mfr report numbers: 1.3005168196-2021-02213; 2.3005168196-2021-02214; 3.3005168196-2021-02216; 4.3005168196-2021-02217.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12595122
• Report Number: 3005168196-2021-02215
• Device Sequence Number: 19675477
• Product Code: HCG
• UDI-Device Identifier: 00814548017006
• UDI-Public: 00814548017006
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021
• 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: 12/04/2021
• Device Model Number: 400SMTSFT3H06
• Device Catalogue Number: 400SMTSFT3H06
• Device Lot Number: F73015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• 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: 09/13/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005