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

Catalog Number	4004C0615
Medical Device Problem Codes	Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Sedation (2368); Ventilator Dependent (2395); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is implanted in the patient, however, the pusher assembly is available for return.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 middle cerebral artery (mca) using penumbra coils 400 (pc400's).During the procedure, after advancing and deploying a pc400 in the aneurysm, the physician decided to reposition it.While attempting to reposition the pc400, the physician noticed that the pc400 had unintentionally detached.The physician then attempted to use saline to flush the detached pc400 into the aneurysm; however, it was unsuccessful and the pc400 migrated out of the aneurysm and partially occluded the mca.Next,the physician attempted to use a snare device to remove the detached pc400 from the mca; however, retrieval of the detached pc400 was unsuccessful as well.Therefore, the procedure was ended at this point, and the patient was transferred to the intensive care unit with hemodynamic instability.The patient continues with ventilator support and is under sedation, and is considered stable and has pneumonia as of (b)(6) 2017.
Additional Manufacturer Narrative
Results: the pet lock on the proximal end of the coil was intact.The pc400 pusher assembly was kinked approximately 5.0 cm from the proximal end of the pusher assembly.The proximal constraint sphere was present inside the distal detachment tip (ddt); the stretch resistant wire (sr wire) was fractured and visible inside the proximal constraint sphere.Conclusions: evaluation of the device revealed the sr wire was fractured inside the proximal constraint sphere.This type of damage is likely a result of forceful attempts to retract the embolization coil against resistance.The root cause of the resistance could not be determined.Repeated attempts to place and reposition the coil likely contributed to the eventual failure of the sr wire.Further evaluation revealed the pusher assembly was kinked.This damage is likely incidental and likely occurred during packaging for return to penumbra facilities.Penumbra coils are 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.
Additional Manufacturer Narrative
The following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report:3005168196-2017-00069.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6255038
• Report Number: 3005168196-2017-00069
• Device Sequence Number: 665194
• Product Code: HCG
• UDI-Device Identifier: 00814548010885
• UDI-Public: 00814548010885
• Combination Product (Y/N): Y
• Initial Reporter Country: GT
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2016
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/09/2023
• Device Catalogue Number: 4004C0615
• Device Lot Number: F66896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/18/2016
• Supplement Date Received by Manufacturer: Not provided; 01/14/2005
• Initial Report FDA Received Date: 01/16/2017
• Supplement Report FDA Received Date: 05/31/2017; 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005