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

Model Number RBYPODJ30-A

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

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

Event Date 10/29/2021

Event Type  Injury  

Manufacturer Narrative

Evaluation of the returned pod pc revealed that the embolization coil was detached from the pusher assembly, and the complaint was confirmed.Evaluation revealed that the proximal constraint sphere was present within the ddt, and the sr component was fractured.If the pod pc is forcefully retracted against resistance, damage such as this may occur.The root cause of resistance during the procedure could not be determined.Further evaluation revealed bends throughout the length of the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return.Penumbra products 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 collateral vessel off of the subclavian artery using pod packing coils (pod pcs) and a lantern delivery microcatheter (lantern).During the procedure, the physician placed the pod pc into the target vessel; however, the pod pc was long and therefore, the physician decided to remove the pod pc.While retracting the pod pc, slight resistance was encountered as the distal portion of the pod pc was stuck in the target vessel and the coil broke in the middle.Subsequently, half of the pod pc was retracted out of the lantern; however, approximately 10-15cm of the coil was left in the target vessel.The physician then used a snare device to remove part of the pod pc; however, they were unable to remove all parts of the pod pc from the patient.The procedure ended at this point.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: 12863350
• MDR Text Key: 281164876
• Report Number: 3005168196-2021-02674
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017655
• UDI-Public: 00814548017655
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,11/23/2021

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: RBYPODJ30-A
• Device Catalogue Number: RBYPODJ30
• Device Lot Number: F105220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• 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: 11/01/2021
• Initial Date FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 9 YR
• Patient Sex: Female