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

Catalog Number	400SMTXSFT0103
Medical Device Problem Codes	Failure to Advance (2524); Appropriate Device Problem Term/Code Not Available (3191); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-00566.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior choroidal artery using penumbra smart coils (smart coils).During the procedure, the physician experienced resistance and was not able to advance the smart coil into the non-penumbra microcatheter.Therefore, the physician removed the smart coil and attempted to advance a new smart coil; however, the same issue occurred.It was reported that the physician noticed a space between the tip of the introducer sheath of the smart coil and the hub of the microcatheter.Subsequently, the procedure was completed using a new smart coil with the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra distributor indicated that the device was disposed of and is no longer available for return.Therefore, 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: 1.3005168196-2019-00566.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up 3005168196-2019-00567 mfr report: this device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8454189
• Report Number: 3005168196-2019-00567
• Device Sequence Number: 14113369
• Product Code: HCG
• UDI-Device Identifier: 00814548015194
• UDI-Public: 00814548015194
• Combination Product (Y/N): Y
• Initial Reporter Country: LE
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2019
• 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: 12/18/2021
• Device Catalogue Number: 400SMTXSFT0103
• Device Lot Number: F73219
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 05/02/2019; 05/02/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 06/28/2019; 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005