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

Model Number	400SMTXSFT0406
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed that the embolization coil was intact with its pusher assembly.Further evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly; this indicates that no attempt was made to properly detach the smart coil.If the smart coil pusher assembly is not properly inserted into a handle prior to the handle being actuated, the pet lock will not separate, the pull wire will not retract, and the coil will not detach.During functional testing, the smart coil was detached using a demonstration handle without an issue.Penumbra coils are 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: 3005168196-2021-02623, 3005168196-2021-02624, 3005168196-2021-02625, 3005168196-2021-02626.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using penumbra smart coil detachment handles (handle), penumbra smart coils (smart coil), packing coil lps, a non-penumbra microcatheter, and a guidewire.During the procedure, the physician successfully detached a smart coil in the target vessel using a handle.The physician then advanced another smart coil to the target vessel and attempted to detach it using the handle; however, the smart coil failed to detach after multiple attempts.Therefore, the smart coil was removed.Next, the physician successfully detached a packing coil lp in the target vessel using a second handle.The physician then advanced another packing coil lp to the target vessel and attempted to detach it using the handle; however, the packing coil lp also failed to detach after multiple attempts.Therefore, the packing coil lp was removed.Then, the same issue occurred with another packing coil lp.It was reported that a second attempt made to detach the packing coil lp with the first handle was also unsuccessful.Therefore, the physician manually detached the packing coil lp.The procedure was completed at this point as the physician lost access.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12841351
• Report Number: 3005168196-2021-02622
• Device Sequence Number: 19921588
• Product Code: HCG
• UDI-Device Identifier: 00814548015385
• UDI-Public: 00814548015385
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2021
• 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: 05/05/2026
• Device Model Number: 400SMTXSFT0406
• Device Catalogue Number: 400SMTXSFT0406
• Device Lot Number: F106011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• 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: 10/24/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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: 64 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005