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

Model Number 4006U0304-A

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400) and a px slim delivery microcatheter (px slim).During the procedure, the physician implanted the initial pc400s into the target vessel using the px slim.While advancing the next pc400 into the target vessel, the pusher assembly of the pc400 kinked and broke.However, the pc400 remained attached to its pusher assembly.The physician then detached the pc400 with part of the pc400 in the px slim and the other part of the pc400 in the target location.Subsequently, the physician successfully pushed the remaining part of the pc400 into the target vessel using a guidewire.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned pc400 revealed that the pusher assembly was fractured, and the embolization coil was detached, and the complaint was confirmed.The probable cause of the reported failure likely occurred due to mishandling of the device during advancement.If the pc400 is forcefully mishandled at an extreme angle during advancement, damage such as a kink and subsequent fracture may occur.If the two fractured pusher assembly segments are separated, the pull wire may retract out of the distal detachment tip (ddt), and the embolization coil will detach from the pusher assembly.The detached embolization coil was not returned for evaluation.Penumbra products are visually 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
• MDR Report Key: 12448038
• MDR Text Key: 270806788
• Report Number: 3005168196-2021-01988
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548019505
• UDI-Public: 00814548019505
• Combination Product (y/n): Y
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4006U0304-A
• Device Catalogue Number: 4006U0304
• Device Lot Number: F103206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1