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

Catalog Number RBYPODJ45

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

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

Event Date 08/17/2022

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using pod packing coils (pod pcs) and a lantern delivery microcatheter (lantern).It should be noted that the patient's anatomy was tortuous and calcified.During the procedure, the physician successfully implanted two pod pcs into the target location.When the next pod pc was advanced approximately fifty centimeters into the vessel, resistance was encountered.The physician attempted to retract the pod pc pusher wire and noticed that the coil was unintentionally detached.The pusher wire was removed from the lantern and a syringe was used to flush the pod pc into the target location.Upon removal, the pod pc pusher wire was broken approximately two centimeters from the detachment zone.It was reported that the coil and a piece of the distal tip of the pusher wire were implanted; however, imaging of the target site did not confirm this.No attempts were made to remove the piece of the pusher wire.At this point, the procedure was successfully completed.There was no report of an adverse effect to the patient.

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• 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 ; 510748-320
• MDR Report Key: 15442034
• MDR Text Key: 305176680
• Report Number: 3005168196-2022-00436
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017662
• UDI-Public: 814548017662
• 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: 01/01/2005,09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F00000253
• Was Device Available for Evaluation?: No
• 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: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1