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

Model Number	RBYPOD5-A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod5 confirmed the embolization coil was detached from the pusher assembly.Further evaluation revealed that the pusher assembly was fractured, and the pull wire was retracted out of the distal fractured segment.If the device is forcefully mishandled at extreme angles during use, damage such as a kink and fracture may occur.Subsequently, if the fractured segments are separated, and the pull wire is retracted out of the ddt, the embolization coil will detach.Further evaluation revealed additional pusher assembly kinks.This damage was likely incidental to the reported complaint.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the lumbar artery using pod coils and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, the first pod coil did not fit into the target location after several attempts were made.While retrieving the pod coil, the physician noticed the coil did not follow the movements of the pusher assembly and found that it had detached inside the microcatheter.Therefore, the microcatheter containing the detached pod coil was removed.The procedure was completed using the same microcatheter, one ruby coil, and two pod packing coils (pod pcs).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: 12510246
• Report Number: 3005168196-2021-02104
• Device Sequence Number: 3598169
• Product Code: HCG
• UDI-Device Identifier: 00814548019604
• UDI-Public: 00814548019604
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2021
• 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: RBYPOD5-A
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F98334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• 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: 08/26/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005