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

Catalog Number	RBYPODJ45
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2023
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the supravoderal artery using a pod packing coil (pod packing coil), a ruby coil detachment handle (handle), and a non-penumbra microcatheter.It was reported that the patient's anatomy was tortuous.During the procedure, the physician successfully implanted penumbra coils into the target vessel using the handle.While advancing the pod pc halfway through the microcatheter, the physician experienced resistance.The physician was able to advance the pod pc into the target vessel; however, the physician did not like how the pod pc was landing in the target vessel and began to retract the pod pc.While retracting the pod pc, the physician noticed under fluoroscopy that the pod pc unintentionally detached within the microcatheter.It was reported that the pod pc was implanted into its target location.The procedure was completed at this point.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the supravoderal artery using a pod packing coil (pod pc), a ruby coil detachment handle (handle), and a non-penumbra microcatheter.It was reported that the patient''s anatomy was tortuous.During the procedure, the physician successfully implanted penumbra coils into the target vessel using the handle.While advancing the pod pc halfway through the microcatheter, the physician experienced resistance.The physician was able to advance the pod pc into the target vessel; however, the physician did not like how the pod pc was landing in the target vessel and began to retract the pod pc.While retracting the pod pc, the physician noticed under fluoroscopy that the pod pc unintentionally detached within the microcatheter.It was reported that the pod pc was implanted into its target location.The procedure was completed at this point.There was no report of an adverse effect to the patient.

• Brand Name: POD PACKING COIL
• Common Device Name: 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: 17505180
• Report Number: 3005168196-2023-00384
• Device Sequence Number: 12359432
• Product Code: HCG
• UDI-Device Identifier: 00814548017662
• UDI-Public: 814548017662
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F99984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Date Report Sent to FDA: 01/01/2005