MAUDE Adverse Event Report: PENUMBRA, INC. POD 3; HCG, KRD

Catalog Number	RBYPOD3
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	12/14/2018
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 pulmonary artery using pod3 coils.During the procedure, the physician felt resistance while advancing the first pod3 into a lantern delivery microcatheter (lantern) and could only advance the pod3 approximately 10cm into the hub.The pod3 was then withdrawn and removed.The physician then found that the pod3 was able to advance through its introducer sheath without issue outside of the patient.Upon attempting to re-advance the pod3 into the lantern again, the same issue occurred.The pod3 was therefore removed.The procedure was completed using another pod3 and the same lantern.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 pusher assembly was kinked approximately 10.5 cm from the proximal end.The pusher assembly had bends approximately 22.0, 60.0 and 109.0 cm from the proximal end.The embolization coil was intact with the pusher assembly distal detachment tip.Offset coil winds were present in the middle of the embolization coil.Conclusions: evaluation of the returned pod3 revealed an embolization coil with offset coil winds.If the introducer sheath is not properly aligned with the hub of the parent device, resistance may be experienced during attempts to advance the device.If the pod3 is forcefully advanced against resistance, damage such as offset coil winds may occur.During functional testing the pod3 took shape within the hub of a demonstration lantern at the site of the offset coil winds.A subsequent attempt to advance the pod3 was able to advance the device through its introducer sheath and the demonstration lantern.Further evaluation revealed kinks and bends along the device pusher assembly.Some of the kinks and bends may have occurred during attempts to forcefully advance the device against resistance.Based on the reported complaint, some of the kinks and bends are incidental to the complaint.Penumbra coils and catheters 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.

• Brand Name: POD 3
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8241888
• Report Number: 3005168196-2019-00075
• Device Sequence Number: 2279331
• Product Code: HCG
• UDI-Device Identifier: 00814548019581
• UDI-Public: 00814548019581
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 12/14/2018
• 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: 06/13/2026
• Device Catalogue Number: RBYPOD3
• Device Lot Number: F84062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Date Report Sent to FDA: 01/01/2005