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

Catalog Number 4004C0513

Device Problems Premature Activation (1484); Retraction Problem (1536)

Patient Problems Infarction, Cerebral (1771); Paralysis (1997); Dysphasia (2195); Ambulation Difficulties (2544)

Event Date 10/20/2014

Event Type  Injury  

Event Description

The patient was undergoing a coil embolization from c2 to c3 using a penumbra coil 400.During the procedure, five penumbra coils were implanted with no problem.While deploying the sixth penumbra coil, it did not fit in the aneurysm; therefore, it was pulled and pushed three times.The physician considered replacing the penumbra coil to another size but thought that it may be difficult to withdraw the delivery wire into the microcatheter.As the physician pulled the delivery wire into the microcatheter tension was felt and the penumbra coil unintentionally detached inside the microcatheter.The penumbra coil then migrated to the m1.The penumbra coil was retrieved using a gooseneck snare through a px slim delivery catheter (this retrieval procedure took approximately 30 minutes).The patient experienced cerebral infarction on the same day.Thrombus attached to the migrated coil, and cerebral infarction occurred at peripheral portion after the shower embolization onset.The physician injected xarbon as a medical treatment.Although the angiography did not indicate blood vessel occlusion, multiple cerebral infarctions were observed peripheral blood vessels on post-mri.Post-operation, the patient developed the right side of the body paralysis.Aphasia was also observed.Approximately four days post-procedure, the patient's condition was recovering and aphasia was recovered.The patient was able to walk with some assistance.Physician's comment: in comparison with other coils, this coil is easy to early-detach.

Manufacturer Narrative

Result: the penumbra coil 400 coil was damaged and detached from the pusher assembly.The pusher assembly was not returned.The coil was detached from the pusher assembly and damaged in several locations.The coil and proximal constraint sphere outer diameter were measured and determined to be within specification.Conclusion: the compliant has been evaluated.The compliant indicates that the penumbra coil 400 unintentionally detached inside the px slim delivery microcatheter.Evaluation of the returned product confirmed that the penumbra coil 400 coil was detached from the pusher assembly; however, unintentional detachment could not be confirmed.The penumbra coil 400 pusher assembly was not returned for evaluation; therefore a full evaluation of the returned product could not be performed.The coil appeared to be damaged from retrieval with a snare device but revealed no other damage.There was no visual damage to the px slim delivery microcatheter.The cause of the detachment is unknown.The coil was intact and dimensionally within specification.The penumbra coil 400 devices are 100% functionally tested during in-process inspection.The catheters are 100% visually inspected for damage 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.; 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: 4270975
• MDR Text Key: 5003508
• Report Number: 3005168196-2014-00816
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2014

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?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 4004C0513
• Device Lot Number: F43753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2014
• Initial Date FDA Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2014
• 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
• Patient Age: 61 YR