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

Catalog Number	400SMTSTD0830
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	02/06/2017
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coils).During the procedure, while attempting to advance a smart coil through another manufacturer¿s microcatheter, the physician experienced strong resistance after advancing the coil about eighty centimeters from the hub of the microcatheter.Subsequently, the smart coil became stuck and was unable to advance further.Therefore, the smart coil was removed and the procedure was completed using a new smart coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The pet lock on the proximal end of the pusher assembly was intact.The pusher assembly was kinked in multiple locations.The embolization coil was intact with its pusher assembly.The outer diameter (od) of the embolization coil was measured and found to be within specification.Evaluation of the returned device revealed that the smart coil was able to be advanced through a demonstration microcatheter and out of the distal tip without issue.The od of the embolization coil was measured and found to be within specification.Further evaluation of the smart coil revealed that the pusher assembly was kinked.This type of damage was likely incidental and may have occurred while packaging the device for return.The root cause of the reported resistance could not be determined.Penumbra coils are visually 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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6393878
• Report Number: 3005168196-2017-00323
• Device Sequence Number: 10921368
• Product Code: HCG
• UDI-Device Identifier: 00814548014524
• UDI-Public: 00814548014524
• 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): 02/08/2017

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: 07/18/2021
• Device Catalogue Number: 400SMTSTD0830
• Device Lot Number: F70705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1