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

Model Number	400SMTSFT0515
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the first returned smart coil confirmed that the coil could not be detached.Further evaluation revealed kinks near the broken pet lock.During the functional test, the returned handle could not be attached to the proximal end of the pusher assembly due to the kinks located by the pet lock.Therefore, the smart coil could not be attempted to be detached using a handle.Resistance was encountered while attempting to manually detach the embolization coil by retracting the broken pet lock, and the pull wire could not be retracted at all.Evaluation of the second returned smart coil could not confirm the coil could not be detached.Further evaluation revealed a broken pet lock, the pull wire was retracted out of the ddt, and the embolization coil was detached from the pusher assembly.This typically occurs during a successful detachment.Evaluation of the returned handle revealed a functional device.The handle was functionally tested on the handle fixture and passed within specification.The handle was used to detach a demonstration coil without an issue.Penumbra devices 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 number: 3005168196-2021-00942.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the lumbar artery using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).It should be noted that the patient's anatomy was tortuous.During the procedure, the physician successfully detached several smart coils using the handle.While attempting to detach the next smart coil using the handle, the coil did not detach.Therefore, the smart coil was removed.The same issue occurred with the next smart coil.Therefore, this smart coil and the handle were also removed from the procedure.The procedure was completed using additional smart coils and a new handle.It was also reported that out of twenty-three smart coils total, two did not detach.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: 11770602
• Report Number: 3005168196-2021-00943
• Device Sequence Number: 17088436
• Product Code: HCG
• UDI-Device Identifier: 00814548014944
• UDI-Public: 00814548014944
• 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
• Report Date (Section B): 04/06/2021
• 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: 02/16/2025
• Device Model Number: 400SMTSFT0515
• Device Catalogue Number: 400SMTSFT0515
• Device Lot Number: F96292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• 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: 04/06/2021
• Initial Report FDA Received Date: 05/04/2021
• 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