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

Catalog Number 4002C2060

Device Problems Detachment Of Device Component (1104); Premature Activation (1484); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device was implanted into the patient.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using penumbra coil 400's (pc400's).It was reported that the patient had excessively tortuous vessels and more time was needed to access the target vessel.During the procedure, the physician advanced a px slim delivery microcatheter (px slim) into the target vessel, then deployed an initial pc400 and attempted to detach it using a penumbra coil detachment handle (handle).However, upon manipulation, a dull sound was heard from the handle and it was observed that the black alignment zone on the pc400 pusher assembly was not separated properly.Next, the physician wiped the alignment zone and made another attempt to detach the pc400 using the handle but was unsuccessful.The physician then applied force in an attempt to manually detach the pc400 while simultaneously pulling the slider on the handle; however, the pc400 did not detach.Therefore, the physician opened a new handle and tested the detachment mechanism to make sure that it clicked.The physician then attempted to detach the pc400 using the new handle but was still unsuccessful and decided to retract the coil.While the pc400 was being retracted, it unintentionally detached inside the px slim.Therefore, the physician flushed the coil into the aneurysm.The procedure was then completed using additional coils and the second handle.The physician did not mention experiencing any resistance while using the pc400.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2017-01028.Device available for evaluation and returned to manufacturer on (removal of text since device was not returned for evaluation).

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6680622
• MDR Text Key: 78812326
• Report Number: 3005168196-2017-01028
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010762
• UDI-Public: 00814548010762
• Combination Product (y/n): Y
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: 4002C2060
• Device Lot Number: A39910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR