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

Catalog Number	4006U0408
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 coil (pc400 coil) pusher assembly.The pusher assembly was fractured approximately 5.0 cm from the proximal end.The embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned device revealed the pusher assembly was fractured.This damage likely occurred due to forceful manipulation of the pc400 at extreme angles.Further evaluation revealed the embolization coil was detached.This likely occurred due to the fracture of the pusher assembly.If the pusher assembly fractures, the pull wire may retract, resulting in detachment of the embolization coil.The px slim mentioned in the complaint was not returned for evaluation.Penumbra coils 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400 coils (pc400 coils).During the procedure, while advancing a pc400 coil through the px slim delivery microcatheter (px slim), the technician kinked the pc400 coil pusher assembly.Therefore, the physician removed both the pc400 coil and the px slim from the patient and then decided to downsize his system.There were no reported issues with the px slim.The procedure was completed using a new pc400 coil and a new microcatheter from another manufacturer.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5585755
• Report Number: 3005168196-2016-00499
• Device Sequence Number: 13522680
• Product Code: HCG
• UDI-Device Identifier: 00814548011493
• UDI-Public: 00814548011493
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 4006U0408
• Device Lot Number: F30488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2016
• Initial Report FDA Received Date: 04/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR