MAUDE Adverse Event Report: PENUMBRA, INC. POD 12; HCG, KRD

Catalog Number	RBYPOD12
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-00391.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod10 coils and pod12 coils.During the procedure, the physician attempted to advance a pod10 into a non-penumbra microcatheter and reported that it was unable to advance beyond the hub.The pod10 was therefore removed and was not used in the procedure.A different pod10 was opened and inserted through the microcatheter but deemed too small.The physician then attempted to advance a pod12 into the microcatheter and experienced resistance.It was also reported that the pod12 was unable to advance beyond the hub of the microcatheter.Consequently, the physician decided to remove the pod12.Upon removal, the pod12 coil partially broke off from its pusher wire and was then fully removed.A pod14 was then chosen and successfully advanced through the microcatheter but was deemed too large and was not used.The procedure was completed using a ruby coil.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.Bends and kinks were present along the pusher assembly.The pusher assembly was fractured at approximately 128.0 cm from the proximal end.The embolization coil was detached from the pusher assembly and was undamaged.Conclusions: evaluation of the returned pod10 revealed a functional device.If the introducer sheath is not properly aligned with the hub of the delivery microcatheter, resistance may be encountered and the device may not be able to be advanced beyond the hub of the microcatheter.During the functional testing, the pod10 was able to be advanced through its introducer sheath and the demonstration px slim without issue.The reported complaint was unable to be confirmed.Evaluation of the returned pod12 confirmed a fractured pusher assembly.If the introducer sheath is not properly aligned within the hub of the delivery microcatheter, resistance may be encountered while advancing the device.If the pod12 is forcefully retracted against resistance, damage such as a fracture may occur.Further investigation revealed kinks and bends on the pod12 pusher assembly and a detached embolization coil.Based on the return condition and the reported complaint, these damages were likely incidental and may have occurred during packaging for return to penumbra.Evaluation of the returned pod14 confirmed a functional device.The complaint reported that the pod14 was successfully advanced and deemed too large by the physician and subsequently not used.Further investigation revealed bends were along the pod14 pusher assembly.These damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.This report is associated with mfr report number: 3005168196-2019-00391.

• Brand Name: POD 12
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8384465
• Report Number: 3005168196-2019-00392
• Device Sequence Number: 13906067
• Product Code: HCG
• UDI-Device Identifier: 00814548019666
• UDI-Public: 00814548019666
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 01/31/2019
• 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: 03/28/2026
• Device Catalogue Number: RBYPOD12
• Device Lot Number: F82603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 03/02/2019
• Supplement Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005