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

Catalog Number	RBYPODJ60
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2022-00007.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat pelvic congestion syndrome using a ruby coil detachment handle (handle), ruby coils, pod packing coils (podj), and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced a ruby coil in the target vessel using the lantern, then used the handle to detach it.However, after successful detachment of the ruby coil, the pusher assembly of the ruby coil became stuck in the handle.The physician then used a new handle to successfully implant the next ruby coils in the target vessel.Next, the physician advanced a podj in the target vessel using the lantern.While attempting to pull one loop of the podj back to reposition it, the podj unintentionally detached, with part of the podj inside the lantern.Therefore, the lantern containing the detached podj was removed.It should be noted that there was no alleged device deficiency or damage to the lantern after removal.A new lantern was then inserted into the patient and the physician advanced a new podj in the target vessel using the lantern.However, while attempting to reposition the podj, it unintentionally detached.Therefore, the physician made several attempts to remove the detached podj using two snares.It was reported that during the removal attempts, the podj broke into fragments.Subsequently, the physician was able to remove the entire podj and no part of the detached podj was left in the patient.The procedure was completed at this point.There was no noted damage to the second lantern after removal.Additionally, there was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned podj confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the stretch resistant component was fractured.If the podj is retracted against resistance, the embolization coil may fracture and detach.Further evaluation revealed multiple kinks throughout the length of the pusher assembly.This damage was incidental to the reported complaint and the root cause could not be determined.Evaluation of the second returned podj confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the stretch resistant component was fractured.If the podj is retracted against resistance, the embolization coil may fracture and detach.Penumbra coils are 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.This report is associated with mfr report number: 3005168196-2022-00007.H3 other text: placeholder.

• 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: 13227773
• Report Number: 3005168196-2022-00008
• Device Sequence Number: 14433059
• Product Code: HCG
• UDI-Device Identifier: 00814548016733
• UDI-Public: 00814548016733
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022
• 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: RBYPODJ60
• Device Lot Number: F101634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/15/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2020
• 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 Sex: Female
• Date Report Sent to FDA: 01/01/2005