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

Catalog Number	400SMTHXSFT0510
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Out-Of-Box Failure (2311); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra smart coil (smart coil) had offset coils winds in multiple locations along its length.During functional analysis, the smart coil was unable to advance out of its introducer sheath.Conclusions: evaluation of the returned smart coil revealed that it was unable to be advanced out of its introducer sheath.This is likely due to the offset coil winds present on the embolization coil.These offset coil winds may result from improper handling during preparation.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
Event or Problem Description
During preparation for a coil embolization procedure, the hospital staff was unable to remove a penumbra smart coil (smart coil) from its dispenser hoop.Therefore, the smart coil was set aside and was not used in the procedure.The procedure was completed using a new smart coil.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6979591
• Report Number: 3005168196-2017-01805
• Device Sequence Number: 19341941
• Product Code: HCG
• UDI-Device Identifier: 00814548015859
• UDI-Public: 00814548015859
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2017

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: Health Professional
• Device Catalogue Number: 400SMTHXSFT0510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1