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

Model Number	RBYPOD4
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
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 the superior gluteal artery using pod4s, a lantern delivery microcatheter (lantern), and a non-penumbra microcatheter.During the procedure, the pod4 would not advance further through the non-penumbra microcatheter upon contact with blood; therefore, the non-penumbra microcatheter and pod4 were removed.The physician then inserted the lantern into the patient and attempted to advance the same pod4 through the lantern; however, the same issue occurred.Therefore, the pod4 and lantern were removed.The physician then successfully tested a new pod4 through the lantern and the non-penumbra microcatheter on the back table.The procedure was completed using the new pod4 and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pod was received tangled with only half of the embolization coil contained within the sheath.The pull wire was distal to the distal detachment tip (ddt) and the embolization coil was still attached.The embolization coil had been retracted through the friction lock.Offset coil winds were present along the embolization coil.Upon functional testing, the pod was able to be sheathed however the embolization coil was unable to advance out of the introducer sheath due to the damages.Conclusions: evaluation of the returned pod revealed a damaged device.It was reported that the pod was unable to advance when the embolization coil encountered blood in the original non-penumbra microcatheter.If the device is forcefully advanced against resistance, damage such as offset coil winds or the pull wire extending distal to the ddt may occur.These damages may then contribute to additional resistance on subsequent attempts to advance the device.The embolization coil was pulled through the introducer sheath friction before returning to penumbra which may have caused additional damages to the coil.Penumbra devices 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: 9508078
• Report Number: 3005168196-2019-02385
• Device Sequence Number: 11222311
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019
• 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: 08/01/2026
• Device Model Number: RBYPOD4
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F85045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 02/04/2020
• 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