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

Catalog Number 400SMTHXSFT0510

Device Problems Device Difficult to Setup or Prepare (1487); Out-Of-Box Failure (2311); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Patient Involvement (2645)

Event Date 08/24/2017

Event Type  malfunction  

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 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
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6979591
• MDR Text Key: 90962640
• Report Number: 3005168196-2017-01805
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015859
• UDI-Public: 00814548015859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 400SMTHXSFT0510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1