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

Catalog Number 4006U0410

Device Problems Detachment Of Device Component (1104); Occlusion Within Device (1423)

Patient Problems Facial Nerve Paralysis (1846); Occlusion (1984); Complaint, Ill-Defined (2331); Numbness (2415)

Event Date 08/06/2014

Event Type  Injury  

Event Description

The patient was undergoing a coil embolization procedure in the left internal carotid artery (ica) using a penumbra coil 400.During the procedure, as the physician advanced a neuron max to the ica, the patient experienced an occluding vasospasm.A rinsing solution of nimodipine (2 mg) was administered and the vascular spasm improved.The physician experienced resistance while detaching the last coil 400.The coil unintentionally detached before being completely placed in the aneurysm.The physician used two stents to fix the coil to the vessel wall and reduce the risk of thromboembolism.There was regular perfusion of the internal carotid artery and the middle and anterior cerebral arteries.There was no indication of perfusion deficit in the final angiography, which shows all the blood vessel areas of the left internal carotid artery as regular.Following the procedure, the patient experienced speech disturbance, numbness in the right hand, and a slight facial palsy.The event was moderate in severity, with a probable relationship to the penumbra coil 400, probable relationship to the angiographic procedure and unrelated to the disease state.The symptoms improved later that day but did not resolve completely.However, the physician noted that the patient returned to baseline state 48 hours after intervention.

Manufacturer Narrative

Conclusion: the device was implanted in the patient.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.This mdr is associated with mdr 3005168196-2014-00615.Device was implanted in the patient.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 4061644
• MDR Text Key: 4735895
• Report Number: 3005168196-2014-00614
• Device Sequence Number: 1
• Product Code: HCG
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 4006U0410
• Device Lot Number: F40556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2014
• 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
• Patient Outcome(s): Required Intervention