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

Catalog Number	400SMTSTD0830
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 numbers: 3005168196-2017-01037, 3005168196-2017-01039, 3005168196-2017-01040, 3005168196-2017-01041.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils) and two penumbra smart coil detachment handles (sch1s).During the procedure, the physician successfully deployed and detached a smart coil using a sch1.The physician was then unable to detach another smart coil using the sch1; therefore, a new sch1 was opened and the smart coil was successfully detached.The physician then successfully placed additional coils.The physician then experienced difficulty detached another smart coil; however was able to detach after three attempts with a sch1.A new sch1 was then opened to be used with further coils.After successfully placing more coils, the physician again experienced difficulty detaching another smart coil; however the smart coil was able to be detached on the second attempt.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Additional information was received on 07/03/2017 following receipt of the returned devices confirming that this is a duplicate complaint and was already reported under report number 3005168196-2017-00938.Therefore, please refer to mfr report number 3005168196-2017-00938 and its associated follow-up.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6682768
• Report Number: 3005168196-2017-01038
• Device Sequence Number: 1615636
• Product Code: HCG
• UDI-Device Identifier: 00814548014524
• UDI-Public: 00814548014524
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2017

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: 10/05/2020
• Device Catalogue Number: 400SMTSTD0830
• Device Lot Number: F65962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR