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

Model Number RBYPODJ60-A

Device Problem Premature Separation (4045)

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

Event Date 01/28/2021

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: 3005168196-2021-00381.

Event Description

The patient was undergoing a coil embolization procedure in the subclavian artery using pod packing coils (pod pcs), a lantern delivery microcatheter (lantern), a non-penumbra parent catheter, and sheath.During the procedure, the physician implanted four non-penumbra coils.While attempting to implant a pod pc, the physician encountered resistance near the hub of the lantern.After the pod pc was advanced into the target location, it was re-positioned several times before it unintentionally detached.Angiography imaging revealed that the tip of the detached pod pc was inside the vessel and may have been caught in the coil pack.The rest of the coil was inside the parent catheter and therefore, a snare device was used to retrieve the pod pc.Next, while advancing another pod pc through the middle of the lantern, the physician encountered resistance.Therefore, the pod pc was removed.The procedure was completed using thirteen non-penumbra coils and two pod pcs with the same lantern, guide catheter, and sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the first pod coil confirmed that the pod coil embolization coil was detached from its pusher assembly.The proximal constraint sphere was present on the proximal end of the embolization coil and the pusher assembly was not returned for evaluation; therefore, the root cause of the embolization coil detaching from its pusher assembly during the procedure could not be determined.Further evaluation of the returned pod coil¿s embolization coil revealed offset coil winds throughout its length.This damage likely occurred due to the snaring to retrieve the coil and was incidental to the reported complaint.Evaluation of the second pod coil revealed a kinked and fractured pusher assembly.If the pod pc is forcefully advanced against resistance, damage such as a kinked in the pusher assembly may occur.Further manipulation of a kinked pusher assembly may result into a fractured.The root cause of the initial resistance could not be determined.Further evaluation revealed that the embolization coil was detached from its pusher assembly.If the two fractured segments are separated and the pull wire is retracted out of the ddt, the embolization coil will detach from its pusher assembly.Further evaluation of the returned pod coil revealed additional kinks along the pusher assembly.This damage may have been incidental to the reported complaint.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of unintentional detachment.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 number: 1.3005168196-2021-00381.H3 other text: placeholder.

• Brand Name: POD PACKING COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11417881
• MDR Text Key: 239781684
• Report Number: 3005168196-2021-00380
• 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: 01/01/2005,02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: F98979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR