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

Catalog Number	4002C0830
Medical Device Problem Codes	Detachment Of Device Component (1104); Kinked (1339); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
While preparing a new penumbra coil 400 (pc400) on the back table for a coil embolization procedure, the physician noticed that the pc400 was already detached upon removal from its packaging hoop.Additionally, the pc400 pusher assembly became kinked upon retracting the coil back into its packaging hoop.The pc400 became detached and the pusher assembly became damaged prior to use.Therefore, the pc400 was not used in the procedure and the procedure was completed using a new pc400.
Additional Manufacturer Narrative
Results: the penumbra coil 400 (pc400) pusher assembly was fractured approximately 30.0 cm from the proximal end.The embolization coil was detached.The pusher assembly and introducer sheath were damaged along their length.The pc400 was detached and therefore, could not be functionally tested.Conclusions: evaluation of the returned pc400 revealed that the pusher assembly was fractured and the embolization coil was detached.If the pusher is removed from the packaging hoop at extreme angles, the pusher assembly may become kinked.If the pusher is further manipulated, it may fracture, which would allow the pull wire to retract from the distal detachment tip (ddt) and effectively detaching the embolization coil.Further evaluation revealed damage along the length of the pusher assembly and introducer sheath.These damages were likely incidental and likely occurred during packaging for return to penumbra.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7314903
• Report Number: 3005168196-2018-00491
• Device Sequence Number: 13910023
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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: 09/28/2024
• Device Catalogue Number: 4002C0830
• Device Lot Number: F71858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1