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

Model Number	400SMTHXSFT0101
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2020
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.This report is associated with mfr report numbers: 3005168196-2020-01083, 3005168196-2020-01084, 3005168196-2020-01085, 3005168196-2020-01086, 3005168196-2020-01088, 3005168196-2020-01089.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery.During the procedure, the patient¿s vessel was perforated using a non-penumbra guidewire.The physician attempted to use penumbra smart coils (smart coils) to stop the bleeding; however, six smart coils would not advance past their initial positions within the introducer sheaths.Therefore, the smart coils were not used in the procedure.The next three smart coils were implanted in the target location using the penumbra smart coil detachment handle (handle).While attempting to implant the next smart coil using the handle, it would not detach.The physician attempted to manually detach the smart coil without success; therefore, this smart coil was removed from the patient.The procedure was completed using five smart coils and the same handle.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: 10354072
• Report Number: 3005168196-2020-01087
• Device Sequence Number: 19599257
• Product Code: HCG
• UDI-Device Identifier: 00814548015590
• UDI-Public: 00814548015590
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2020
• 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: 05/03/2025
• Device Model Number: 400SMTHXSFT0101
• Device Catalogue Number: 400SMTHXSFT0101
• Device Lot Number: F97660
• 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: 07/10/2020
• Initial Report FDA Received Date: 08/01/2020
• 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