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

Catalog Number RBYPODJ30

Device Problems Failure to Fold (1255); Premature Separation (4045)

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

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned pod pc confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the pet lock was separated, and the pull wire was retracted out of the pusher assembly distal tip.If the pet lock is inadvertently separated and the pull wire is retracted out of the pusher assembly distal tip, the embolization coil will detach from its pusher assembly.The complaint indicated that the pod pc had been pulled back several times.This likely contributed to the separation of the pet lock.Further evaluation of the device revealed that the embolization coil had offset coil winds throughout its length.If the pod pc is advanced against resistance, damage such as this may occur.This damage may have contributed to the reported issue of the pod pc not fitting into the target vessel.Further evaluation also revealed a kink in the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging for return to penumbra.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 internal iliac artery (iia) using a lantern delivery microcatheter (lantern), pod packing coils (pod pc), and a non-penumbra sheath.It should be noted that the patient¿s anatomy was moderately tortuous.During the procedure, the physician successfully implanted two non-penumbra coils and four pod pcs into the target vessel using the lantern.Another coil was advanced to the target vessel; however, the pod pc would not take its intended shape.After several strokes of pulling the pod pc back, the pod pc unintentionally detached within the lantern.Therefore, the lantern containing the pod pc was removed.It was reported that the pod pc was flushed out of the lantern.The procedure was completed using a new pod pc, the same lantern, and the same sheath.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: 18803914
• MDR Text Key: 337629226
• Report Number: 3005168196-2024-00064
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,02/28/2024

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: Health Professional
• Device Catalogue Number: RBYPODJ30
• Device Lot Number: F00004604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• 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
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2022
• 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