MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400 DETACHMENT HANDLE; HCG, KRD

Model Number	DH1
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hepatic artery using a penumbra coil 400 detachment handle (handle) and penumbra smart coils.During the procedure, the physician implanted a smart coil into the target location using the handle.However, the smart coil pusher wire became stuck in the handle.Therefore, the handle was removed.The procedure was completed using a new handle and smart coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report 3005168196-2020-02060.Previously, it was incorrectly understood that a new handle and smart coils were used to complete the procedure.However, no additional coils were implanted following the reported incident and the procedure ended after the placement of one penumbra coil 400 (pc400).Therefore, there was no delay in case.Note: although the event summary alleged a deterioration in the characteristics or performance of the device, this event did not and, if it were to recur, it would not cause or contribute to serious injury or death.Therefore, this is not considered a reportable event.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hepatic artery using a penumbra coil 400 detachment handle (handle) and penumbra coil 400s (pc400s).During the procedure, the physician implanted one pc400 into the target location using the handle.However, the pc400 pusher wire became stuck in the handle.Therefore, the handle was removed.No additional coils were implanted following the reported incident and the procedure was therefore ended.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400 DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10879551
• Report Number: 3005168196-2020-02060
• Device Sequence Number: 16972975
• Product Code: HCG
• UDI-Device Identifier: 00814548011974
• UDI-Public: 00814548011974
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021
• 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: 02/18/2023
• Device Model Number: DH1
• Device Catalogue Number: DH1
• Device Lot Number: F96325
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 07/21/2021
• 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