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

Catalog Number	400SMTXSFT0204
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
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 left middle cerebral artery (mca) using penumbra smart coils (smart coil), a penumbra smart coil handle (handle), a non-penumbra microcatheter, a guidewire, and a stent device.During the procedure, the physician successfully implanted a smart coil in the aneurysm using the microcatheter.The second smart coil was advanced in the target location using the microcatheter and the physician attempted to detach it using the handle; however, the smart coil failed to detach.The physician then made multiple attempts to detach the smart coil using the handle and by manually detaching it using medical clamps but were unsuccessful.Therefore, the smart coil was removed.Next, the physician implanted the next smart coil in the aneurysm using the microcatheter.The next smart coil was then advanced in the aneurysm using the microcatheter and the physician attempted to detach it using the handle; however, the smart coil failed to detach.Therefore, the physician manually detached the smart coil using medical clamps.Another smart coil was then advanced in the aneurysm using the microcatheter and the physician attempted to detach it using the handle; however, the smart coil failed to detach.The physician then made multiple attempts to detach it using the handle and by manually detaching it using medical clamps but were unsuccessful.Therefore, the physician decided to remove the smart coil.While retracting the smart coil, the smart coil unintentionally detached with half of the smart coil outside the aneurysm.The physician then used a microwire to successfully push half of the smart coil back into the aneurysm.Subsequently, the microcatheter prolapsed back deploying some of the smart coil into the mca artery.Consequently, the smart coil was restricting flow to the m2 branches of the mca.Therefore, the physician implanted a stent to tack down the smart coil in the mca that restored the flow to the m2 branches.The procedure ended at this point.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: 15100746
• Report Number: 3005168196-2022-00353
• Device Sequence Number: 17499710
• Product Code: HCG
• UDI-Device Identifier: 00814548015286
• UDI-Public: 814548015286
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2022
• 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 Catalogue Number: 400SMTXSFT0204
• Device Lot Number: F112082
• Was Device Available for Evaluation?: No
• 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: 06/28/2022
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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: 67 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005