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

Model Number RBYPODJ60-A

Device Problems Break (1069); Unraveled Material (1664); Premature Separation (4045)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  Injury  

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.This report is associated with mfr report number: 3005168196-2021-00106.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils, pod packing coils (pod pcs), a lantern delivery microcatheter (lantern), and an angiographic catheter (5f).During the procedure, two coils were implanted into the target location.While advancing a ruby coil, it detached inside the microcatheter; therefore, the ruby coil and microcatheter were removed from the patient together.After removing the ruby coil, the lantern was re-advanced and three other coils were implanted in the target vessel.Next, while advancing a pod pc, almost the entire pod pc coil was inside the target vessel when it prematurely detached.The physician was unable to retrieve the pod pc using a goose-neck snare.It was also reported that the pod pc unraveled and broke off twice.The physician was able to retrieve a part of the coil with the snare and the procedure was then ended.On (b)(6) 2020, a post-operative computed tomography (ct) scan revealed that the remaining unraveled coil moved from the splenic artery towards the aorta and the patient was in stable condition.Therefore, no further action was taken to remove the remaining pod pc.

Manufacturer Narrative

Evaluation of the returned ruby coil confirmed a detached embolization coil.Further evaluation revealed that the pet lock was not separated, and the pull wire was within the pusher assembly ddt.If the ruby coil is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and allow the embolization coil to detach.Further evaluation revealed a pusher assembly bend and kink and the embolization coil had offset coil winds.This damage was likely incidental to the reported complaint.Evaluation of the returned pod pc confirmed that the embolization coil was detached from the pusher assembly and was unraveled.Further evaluation revealed that the pull wire was in its initial position within the pusher assembly ddt, and the proximal constraint sphere was fractured off the embolization coil and not returned for evaluation.If the device is forcefully retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire, allowing the embolization coil to detach.The unraveled embolization coil was likely a result of the coil being reportedly broken while snaring the device during removal.Evaluation of the returned lantern revealed an ovalization on the distal shaft.If the rotating hemostasis valve (rhv) is over-tightened onto the lantern, damage such as this may occur.During functional testing, a demonstration ruby coil was advanced through the lantern with resistance.The ovalization may have contributed to some resistance experienced during the procedure and the functional test.Penumbra coils and catheters 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.This report is associated with mfr report numbers: 1.3005168196-2021-00106, 2.3005168196-2021-00665.

• Brand Name: POD PACKING COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11197743
• MDR Text Key: 227794996
• Report Number: 3005168196-2021-00107
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017679
• UDI-Public: 00814548017679
• Combination Product (y/n): Y
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYPODJ60-A
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F98205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• 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: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR