MAUDE Adverse Event Report: PENUMBRA, INC. POD4; HCG, KRD

Catalog Number	RBYPOD4
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
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 a branch of the collateral vessel using pod4s.During the procedure, while advancing a pod4 through a non-penumbra microcatheter, the pod4 unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached pod4 was removed.The procedure was completed using a new pod4 and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The distal detachment tip (ddt) was detached from the pusher assembly.The ddt was not returned for evaluation.Conclusions: evaluation of the returned pod4 revealed the ddt was detached from the pusher assembly.This type of damage typically occurs if the device is forcefully retracted against resistance.The pusher assembly ddt keeps the embolization coil intact with the pusher assembly; therefore, if the ddt fractures from the pusher assembly, the embolization coil will detach.The non-penumbra microcatheter identified in the complaint and the pod4 embolization coil were not returned for evaluation.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.

• Brand Name: POD4
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9406956
• Report Number: 3005168196-2019-02229
• Device Sequence Number: 11375126
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141134
• 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,Followup
• Report Date (Section B): 11/06/2019
• 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: 06/14/2024
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F70171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005