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

Model Number	RBYPOD4
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	07/13/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the profunda femoris artery using a pod coil and a non-penumbra microcatheter.During the procedure, the physician experienced resistance while advancing the pod coil through the microcatheter and subsequently, the pod coil unintentionally detached.Therefore, the microcatheter containing the detached pod coil was removed.The procedure was completed using other coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up # 02 mfr report: 1.Section d.Box 4.Lot#.2.Section d.Box 4.Expiration date.3.Section d.Box 4.Unique identifier.4.Section h.Box 4.Manufacture date h3 other text : placeholder.
Additional Manufacturer Narrative
Evaluation of the returned pod coil confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the pet lock was intact, and the pull wire was in its original position within the ddt.If the pod coil is inadvertently manipulated against resistance, the pusher assembly may elongate beyond the reach of the pull wire and allow the embolization coil to detach from its pusher assembly.The detached embolization coil was not returned for evaluation.Further evaluation revealed kink along the length of the pusher assembly.This damage was incidental to the reported complaint and the root cause could not be determined.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.H3 other text : placeholder.

• Brand Name: POD
• 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: 12271697
• Report Number: 3005168196-2021-01740
• Device Sequence Number: 4376731
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• 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,Followup
• Report Date (Section B): 05/10/2022
• 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 Model Number: RBYPOD4
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F88991
• 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: 07/13/2021
• Supplement Date Received by Manufacturer: 03/28/2022; 01/14/2005
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 04/06/2022; 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2019
• 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: 64 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005