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

Catalog Number	4002C0830
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: the pusher assembly of the first evaluated penumbra coil 400 coil (pc400 coil) was fractured approximately 61.0 cm from the distal tip and only the distal portion was returned.Conclusions: evaluation of the first evaluated pc400 coil revealed that the pusher assembly was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against resistance, it may become kinked.If a kinked pusher assembly is further manipulated, it may become fractured.The fractured pusher assembly likely caused the embolization coil to detach inside the microcatheter.Evaluation of the second evaluated pc400 coil revealed that the pusher assembly was kinked.This damage was likely incidental and may have occurred during packaging of the device for return.The outer diameter (od) of the embolization coil was measured and found to be within specification.The other manufacturer¿s microcatheter was not returned for evaluation.The root cause of the pc400 coil getting stuck around the tip of the other manufacturer¿s catheter could not be determined.Pc400 coils are 100% functionally tested during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2016-01105.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) using penumbra coil 400 coils (pc400 coils).During the procedure, the physician initially delivered two coils from another manufacturer and two pc400 coils into the target vessel using another manufacturer's microcatheter.While advancing a new pc400 coil through the microcatheter, the physician experienced resistance and subsequently, the pc400 coil became stuck around the middle of the microcatheter.The physician then decided to retract the pc400 coil; however, while the coil was being retracted, it unintentionally detached within the microcatheter.Therefore, the physician flushed the pc400 coil out of the microcatheter using a syringe and then attempted to advance a new pc400 coil through the microcatheter.However, the new pc400 coil became stuck around the tip of the microcatheter.The physician removed the microcatheter then retracted the pc400 coil from it and completed the procedure using another manufacturers' coils and the same microcatheter.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: 5842002
• Report Number: 3005168196-2016-01104
• Device Sequence Number: 19026110
• Product Code: HCG
• UDI-Device Identifier: 00814548010564
• UDI-Public: 00814548010564
• 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
• Type of Report: Initial
• Report Date (Section B): 07/03/2016

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: Physician
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: 4002C0830
• Device Lot Number: F66783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2016
• Initial Report FDA Received Date: 08/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1