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

Model Number RBYPODJ45-A

Device Problems Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results: the pet lock was damaged on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 42.0 cm from the proximal end.The pull wire was retracted from the pusher assembly distal detachment tip (ddt) and the embolization coil was detached from the pusher assembly.The proximal constraint sphere was intact with the embolization coil and the embolization coil had offset coil winds along its length.Conclusions: evaluation of the returned pod pc confirmed that the pusher assembly was fractured.If the pod pc is forcefully advanced against resistance, the pusher assembly may become kinked and may subsequently fracture.If the pusher assembly is fractured, and the pull wire is retracted out of the ddt, the embolization coil will detach from the pusher assembly.The root cause of resistance experienced during the procedure could not be determined.Further evaluation of the device revealed that the pet lock was damaged, and the embolization coil had offset coil winds.This damage was likely incidental to the reported complaint.Penumbra coils 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.

Event Description

The patient was undergoing a coil embolization procedure in the lumbar artery using pod packing coils (pod pcs) and a lantern delivery microcatheter (lantern).It was noted that the patient's anatomy was tortuous.During the procedure, while attempting to implant the first coil, the physician encountered resistance when the distal tip of the pod pc was advanced into the middle of the lantern.Next, the pod pc pusher wire kinked and broke and the pod pc became detached in the lantern.Therefore, the pod pc was removed.The procedure was completed using seven pod pcs and one non-penumbra coil with the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: POD PACKING COIL
• 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: 10871288
• MDR Text Key: 217391295
• Report Number: 3005168196-2020-02040
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017662
• UDI-Public: 00814548017662
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYPODJ45-A
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F97378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Is the Reporter a Health Professional?: Yes
• 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: 10/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2020
• 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
• Patient Weight: 65