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

Catalog Number	400SMTSTD1460
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/25/2017
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: 3005168196-2018-00213, 3005168196-2018-00214.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) to the inferior mesenteric artery (ima) to treat a type ii endoleak using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician deployed and detached two smart coils into the target vessel using a non-penumbra microcatheter and the handle.The physician then advanced a new smart coil into the target vessel and attempted to detach it using the same handle; however, the smart coil would not detach.After five attempts, the smart coil finally detached.The physician then advanced another smart coil into the target vessel and attempted to detach it using the same handle but the coil did not detach.After several attempts, the smart coil would still not detach.The physician then partially pulled back the lever of the handle and manually held it in order to adjust the force; however, the smart coil did not detach.Therefore, the physician used forceps to manually detach the smart coil.Thereafter, the procedure was completed using a new handle and additional smart coils.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: 7217370
• Report Number: 3005168196-2018-00215
• Device Sequence Number: 10793878
• Product Code: HCG
• UDI-Device Identifier: 00814548014289
• UDI-Public: 00814548014289
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2017

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: Physician
• Device Expiration Date: 04/19/2022
• Device Catalogue Number: 400SMTSTD1460
• Device Lot Number: F75778
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR