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

Model Number	400SMTSFT0820
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Serious Injury
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.This report is associated with mfr report number: 3005168196-2021-01468.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right middle cerebral artery (mca) using penumbra smart coils (smart coil), penumbra smart coil detachment handles (handle) and a non-penumbra microcatheter.It was reported that the patient was in a coma before the procedure.During the procedure, the physician used a dual microcatheter technique.A 7x15 smart coil was advanced into the target location through the first microcatheter and the physician attempted to detach it using the handle; however, the smart coil failed to detach.The physician tried multiple times to detach the smart coil, but the smart coil wouldn't detach.Therefore, the physician decided to remove the coil.While retracting the smart coil, it unintentionally detached with approximately 1cm inside the microcatheter.At this point, the physician decided to place the 8x20 smart coil in the aneurysm through the second microcatheter without detaching it.Next, he decided to push the rest of the 7x15 smart coil using the pusher assembly through the first microcatheter.The physician was able to push 7x15 smart coil in the aneurysm; however, a loop was seen.The physician assumed that loop came from the 8x20 smart coil in the second microcatheter.The physician retracted the 8x20 smart coil to reposition it; however, the 8x20 smart coil unintentionally detached with approximately 10cm inside the 2nd microcatheter.The physician then attempted to snare the coils using a stent retriever and other methods but was unsuccessful; therefore, the detached smart coils were left in the patient.The procedure was completed at this point.There is no reported 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: 12111546
• Report Number: 3005168196-2021-01469
• Device Sequence Number: 19759173
• Product Code: HCG
• UDI-Device Identifier: 00814548014753
• UDI-Public: 00814548014753
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2021
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2025
• Device Model Number: 400SMTSFT0820
• Device Catalogue Number: 400SMTSFT0820
• Device Lot Number: F101173
• Was Device Available for Evaluation?: No
• 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: 06/04/2021
• Initial Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Date Report Sent to FDA: 01/01/2005