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

Model Number	400SMTHXSFT0102
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acomm) using penumbra smart coils (smart coil), penumbra smart coil detachment handles (handle), and a non-penumbra microcatheter.During the procedure, the physician placed and detached two smart coils in the target location using the first handle.The physician then advanced another smart coil into the target location and made multiple attempts to detach it using the first handle; however, the smart coil failed to detach.Therefore, the smart coil was removed.Subsequently, the physician advanced another smart coil and attempted to detach it using a second handle but had difficulty detaching.The physician then used his fingers to manually detach the coil and successfully implanted the smart coil.The procedure was completed at this point.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 not detached from the pusher assembly.The embolization coil was intact with its pusher assembly.Evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly, the pull wire was fractured off, and the embolization coil had offset coil winds.The pet lock separated on the proximal end of the pusher assembly likely occurred during the attempt to detach the embolization coil using the handle, during the procedure.The root cause of the fractured pull wire could not be determined.The offset coil wind on the proximal end of the embolization coil may have occurred due to manipulation against resistance during the detachment attempts.Based on the returned condition, the smart coil could not be functionally tested.Further evaluation revealed pusher assembly kinks.This damage was incidental to the reported complaint and likely occurred while packaging the device for return.Evaluation of the returned handle revealed a functional device.During the functional test, the handle was tested on the handle fixture and passed within specifications.The returned handle was able to detach a demonstration smart coil without an issue.Penumbra products 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.This report is associated with mfr report numbers: 3005168196-2021-02523, 3005168196-2021-02524, 3005168196-2021-02525.

• 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: 12778855
• Report Number: 3005168196-2021-02522
• Device Sequence Number: 3708620
• Product Code: HCG
• UDI-Device Identifier: 00814548015613
• UDI-Public: 00814548015613
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2021
• 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: 12/21/2025
• Device Model Number: 400SMTHXSFT0102
• Device Catalogue Number: 400SMTHXSFT0102
• Device Lot Number: F102913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• 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: 10/12/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2020
• 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 Age: 73 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005