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

Catalog Number 4002C0830

Device Problems Detachment Of Device Component (1104); Kinked (1339); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event 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.

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
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7314903
• MDR Text Key: 101705166
• Report Number: 3005168196-2018-00491
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010564
• UDI-Public: 00814548010564
• 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: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Physician
• Device Catalogue Number: 4002C0830
• Device Lot Number: F71858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 03/09/2018
• Supplement Dates FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• 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