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

Catalog Number	RBYPODJ30
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a retroperitoneal bleed in the internal hypogastric artery using a pod packing coil (podj), a non-penumbra microcatheter and a non-penumbra guide catheter.During the procedure, the physician placed a few penumbra coils in the target vessel using the microcatheter.Next, while attempting to advance the podj through the microcatheter, the physician experienced resistance and therefore, he stopped advancing the podj.The physician pulled back on the microcatheter realizing that the podj had unintentionally detached with more than half of the podj inside the microcatheter.Therefore, the microcatheter was removed.After removing the microcatheter, the physician noticed that the coil was in the guide catheter.The physician then applied negative pressure and removed the guide catheter containing the detached podj.The procedure was completed using packing coil lps, ruby coil lps, a new non-penumbra microcatheter and a new guide catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned pod pc confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the sr component was fractured.If the pod pc is manipulated against resistance during use, damage such as the sr component may fracture.Evaluation of the returned non-penumbra microcatheter revealed ovalization along the catheter shaft.The root cause of this damage could not be determined.However, this damage may have contributed to resistance during the procedure and resulted in the sr component fracture.Penumbra coils 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.

• 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: 13934723
• Report Number: 3005168196-2022-00142
• Device Sequence Number: 14635372
• Product Code: HCG
• UDI-Device Identifier: 00814548016719
• UDI-Public: 00814548016719
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022
• 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 Expiration Date: 06/26/2024
• Device Catalogue Number: RBYPODJ30
• Device Lot Number: F70345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• 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: 03/04/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2016
• 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: 85 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005