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

Model Number	RBYPOD4-A
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
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 right internal mammary artery (rima) using pod coils and a non-penumbra microcatheter.During the procedure, a pod coil was advanced into the microcatheter and became stuck midway.The hospital technologist attempted to pull the pod coil back into the introducer sheath, but the pod coil was unable to completely retract out of the microcatheter.The physician then removed the introducer sheath to find the pod coil stuck in the microcatheter, hanging halfway out and detached from the pusher assembly.Therefore, the physician pulled the detached pod coil out of the microcatheter by hand.It was reported the microcatheter may not have been flushed prior to introducing the pod coil.The procedure was completed using a new pod coil and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: POD
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12424871
• Report Number: 3005168196-2021-01964
• Device Sequence Number: 19711966
• Product Code: HCG
• UDI-Device Identifier: 00814548019598
• UDI-Public: 00814548019598
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2021
• 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 Model Number: RBYPOD4-A
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F95135
• Was Device Available for Evaluation?: No
• 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: 08/13/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Date Report Sent to FDA: 01/01/2005