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

Catalog Number	400SMTXSFT2H06
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2017-00503.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left anterior cerebral artery (aca) using penumbra smart coils (smart coils).During the procedure, the physician successfully placed three non-penumbra coils in the target vessel using a non-penumbra microcatheter.The physician then attempted to place a smart coil in the target vessel.However, while advancing the smart coil, the microcatheter kicked back; therefore the smart coil was retracted.After repositioning the microcatheter, the physician attempted to re-advance the smart coil; however, the smart coil became stuck and unable to advance past the hub of the microcatheter; therefore, it was removed.The physician then attempted to use a new smart coil, however, resistance was experienced while advancing the smart coil through the hub of the microcatheter and the smart coil became stuck.Therefore, the smart coil was removed and the procedure was completed using new coils and the same non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the second smart coil evaluated had an embolization coil with several offset coil winds along its length.Conclusions: evaluation of the device revealed both embolization coils had offset coil winds along their length.This damage may result if the smart coil is advanced before the introducer sheath is properly seated inside the taper of the microcatheter hub.If an embolization coil is already damaged, further attempts to advance the coil will become increasingly difficult.Further evaluation revealed kinks along the pusher assembly.This damage was likely incidental and may have occurred during packaging for return to penumbra facilities.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.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: 3005168196-2017-00503.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6443165
• Report Number: 3005168196-2017-00504
• Device Sequence Number: 830127
• Product Code: HCG
• UDI-Device Identifier: 00814548015330
• UDI-Public: 00814548015330
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/03/2017

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: 04/07/2021
• Device Catalogue Number: 400SMTXSFT2H06
• Device Lot Number: F68860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1