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

Model Number RBYPODJ30-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 right internal mammary arteries (rima) using pod packing coils (pod pcs) and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced the pod pc in the target vessel but decided to retract the coil in order to reposition it.While attempting to retract the pod pc, the physician encountered resistance and the pod pc unintentionally detached partially in the lantern and partially in the vessel.The physician then used a snare device to remove the detached pod pc.The next pod pc also unintentionally detached within the lantern.Therefore, the lantern containing the detached pod pc was removed.The procedure was completed using new pod pcs and the same lantern.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.This report is associated with mfr report number.

Manufacturer Narrative

Please note that the associated report number was inadvertently missed on the initial mfr report and is being included in this follow-up #01 mfr report: 3005168196-2021-02799 this report is associated with mfr report numbers: 1.3005168196-2021-02800 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 13101875
• MDR Text Key: 287200979
• Report Number: 3005168196-2021-02799
• 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,Followup
• Report Date: 01/01/2005,12/31/2021

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 Model Number: RBYPODJ30-A
• Device Catalogue Number: RBYPODJ30
• Device Lot Number: F107163
• 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
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 12/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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: 1 YR
• Patient Sex: Female