MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number 4004C0710

Device Problems Flushing Problem (1252); Device Difficult to Setup or Prepare (1487); Failure to Advance (2524)

Patient Problem No Patient Involvement (2645)

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

During preparation for a coil embolization procedure, after removing a penumbra coil 400 coil (pc400 coil) from its packaging, the hospital staff was unable to advance the pc400 coil out of its introducer sheath and into the liquid bath (heparinized saline).The hospital staff indicated that there was no resistance on the pc400 coil pusher assembly and no reported damage to the pusher assembly.The pc400 coil was unable to be flushed for use and was not used in the procedure.The physician continued the procedure using a new pc400 coil.

Manufacturer Narrative

Result: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly and the pusher assembly was bent approximately 2.0 and 5.0 cm from the proximal end.The embolization coil was intact with the pusher assembly.Conclusion: evaluation of the returned device revealed it was able to advance and withdraw through the introducer sheath without an issue.The root cause of the complaint could not be determined.Further evaluation revealed the pusher assembly was kinked on the proximal end.This damage was likely incidental and may have occurred during packaging for return.Pc400 devices are 100% functionally evaluated during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5230396
• MDR Text Key: 31405090
• Report Number: 3005168196-2015-01164
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548011691
• UDI-Public: 00814548011691
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 4004C0710
• Device Lot Number: F61907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2014
• 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