MAUDE Adverse Event Report: PENUMBRA, INC. POD8; HCG, KRD

Catalog Number	RBYPOD8
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2018
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 internal iliac artery using pod8s.During the procedure, while advancing a pod8 through a lantern delivery microcatheter (lantern), the physician experienced resistance at about 10cm from the lantern¿s distal tip; therefore, the pod8 was removed.Upon removal, the physician inspected the pod8 and attempted to advance it through the lantern again; however, the pod8 became stuck at the same position in the lantern.Therefore, the pod8 was removed and the procedure was completed using a new pod coil and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the proximal pet lock was intact on the pusher assembly.The pod8 embolization coil was undamaged and intact with its pusher assembly.The pusher assembly¿s mid-joint was retracted proximal to the introducer sheaths friction lock.Dried blood was found inside the introducer sheath.Conclusions: evaluation of the returned pod8 revealed a device capable of advancing through its introducer sheath and a demonstration catheter.During functional testing, the pod8 was able to advance through its introducer sheath and demonstration catheter with minimal resistance after flushing coagulated blood from the introducer sheath.The lantern mentioned in the complaint was not returned for evaluation.Therefore, the root cause of the inability to advance the pod8 was not able to be determined.Based on the reported complaint, the pusher assembly mid-joint being retracted proximal to the introducer sheath friction lock likely happened after the device was removed from the patient or during packaging for return to penumbra.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.

• Brand Name: POD8
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7778404
• Report Number: 3005168196-2018-01569
• Device Sequence Number: 13802750
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018
• 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: 06/04/2025
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F77519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 01/22/2019
• 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