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

Catalog Number	4002C1857
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/07/2015
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 116.0 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.A pusher assembly kink may occur due to improper handling during preparation.If the pc400 is roughly handled during removal of the introducer sheath, the pusher assembly may become kinked.If a kinked pusher assembly is further manipulated, it may become fractured.The detachment of the embolization coil likely occurred when the pusher assembly became fractured.Pc400 devices are 100% functionally and visually 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 in the superior mesenteric artery (sma) using a penumbra coil 400 coils (pc400 coils).During the procedure, the physician deployed and detached fifteen pc400 coils into the aneurysm.The physician then removed a new pc400 coil from its packaging.While advancing this pc400 coil out of its orange-colored introducer sheath, the physician noticed that the pc400 coil pusher assembly was kinked.The kinked pusher assembly was found prior to use.Therefore, the pc400 coil was not used for the procedure and did not enter the patient's body.The physician continued the procedure using a new pc400 coil.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5355799
• Report Number: 3005168196-2016-00019
• Device Sequence Number: 10858338
• Product Code: HCG
• UDI-Device Identifier: 00814548010748
• UDI-Public: 00814548010748
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Report Date (Section B): 12/10/2015

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: Physician
• Device Expiration Date: 08/16/2023
• Device Catalogue Number: 4002C1857
• Device Lot Number: F65366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1