MAUDE Adverse Event Report: PENUMBRA, INC. POD5; HCG, KRD

Catalog Number	RBYPOD5
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 100.5 cm from the proximal end.The embolization coil was detached from its pusher assembly with the constraint sphere intact and the pull wire was retracted out of the distal detachment tip (ddt).Conclusions: evaluation of the returned device revealed that the pod5¿s pusher assembly was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully mishandled during use, the pusher assembly may become kinked.Upon retraction of the kinked pusher assembly against resistance, the kink damage may develop into a fracture.The fractured pusher assembly likely contributed to the pull wire being retracted out of the ddt and allowing the embolization coil to detach from its pusher assembly.The lantern and introducer sheath mentioned in the complaint was not returned for evaluation.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using pod5s.During the procedure, the physician advanced a pod5 through the lantern delivery microcatheter (lantern) and into the vessel; however the pod5 would not take its shape within the vessel.The pod5 was therefore removed, and then it unintentionally detached outside of the patient¿s body as it was retracted into its introducer sheath.The procedure was therefore completed using four ruby coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Correction: corrected ¿returned to manufacturer on¿ to 7/13/2017.

• Brand Name: POD5
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6761278
• Report Number: 3005168196-2017-01328
• Device Sequence Number: 16536727
• Product Code: HCG
• UDI-Device Identifier: 00814548013787
• UDI-Public: 00814548013787
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/11/2017

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: Physician
• Device Expiration Date: 05/14/2024
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F69321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR