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

Model Number RBYPODJ60-A

Device Problems Physical Resistance/Sticking (4012); Premature Separation (4045)

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

Event Date 12/02/2021

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using pod packing coils (pod pcs), ruby coils and a non-penumbra microcatheter.During the procedure, the physician implanted five ruby coils in the target vessel.While attempting to implant the last pod pc into the target vessel, the physician encountered resistance.Therefore, the physician decided to remove the pod pc.While retracting the pod pc to be resheathed, the pod pc unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached pod pc was removed.The physician performed an angiogram after removing the microcatheter and confirmed that the aneurysm was successfully embolized.No further coils were needed; therefore, the procedure was completed at this point.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 ; 5107483200
• MDR Report Key: 13093398
• MDR Text Key: 282826441
• Report Number: 3005168196-2021-02797
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017679
• UDI-Public: 00814548017679
• 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: 01/01/2005,12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYPODJ60-A
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F108908
• 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: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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 Age: 70 YR
• Patient Sex: Female