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

Model Number	400SMTXSFT0101
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2017
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: 3005168196-2017-01179, 3005168196-2017-01180.The device was discarded by the hospital.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the a1 segment of the anterior cerebral artery using penumbra smart coils (smart coils).During the procedure, the physician experienced difficulty while attempting to advance three smart coils out of their introducer sheaths and into a non-penumbra microcatheter.Therefore, the introducer sheaths containing the smart coils were removed and the procedure was completed using another smart coil and the same microcatheter.It was reported that it was difficult to push some of the coils out of their introducer sheaths on the back table.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2017-01181.This report is associated with mfr report numbers: 1.3005168196-2017-01179, 2.3005168196-2017-01180.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6712433
• Report Number: 3005168196-2017-01181
• Device Sequence Number: 19205160
• Product Code: HCG
• UDI-Device Identifier: 00814548015163
• UDI-Public: 00814548015163
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 06/15/2017
• 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: Physician
• Device Expiration Date: 10/13/2021
• Device Model Number: 400SMTXSFT0101
• Device Catalogue Number: 400SMTXSFT0101
• Device Lot Number: F72046
• 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: 06/15/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Date Report Sent to FDA: 01/01/2005