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

Catalog Number	PODH1
Medical Device Problem Codes	Mechanical Problem (1384); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2016
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.This report is associated with mfr report number: 3005168196-2016-00594.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a pod detachment handle (pod handle) and a ruby coil detachment handle (ruby handle).During the procedure, after the physician detached a ruby coil using the pod handle, the ruby coil pusher assembly became stuck in the pod handle.The pod handle was removed and a new ruby handle was opened; however, the ruby handle did not make the usual "clicking" sound and was not used.Therefore, a third ruby handle was used to detach additional ruby coils, one pod coil and one pod packing coil.The procedure was then completed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pod detachment handle (podh1) had the ruby coil¿s pusher assembly stuck inside.The ruby coil¿s pusher assembly was fractured approximately 10.0 cm from the proximal end and kinked in multiple locations along the hypo-tube.Conclusions: evaluation of the returned device confirmed that the ruby coil¿s pusher assembly was stuck inside the podh1.This type of damage typically occurs due to improper handling during use.If the podh1 is actuated multiple times during use, damage such as this may occur.Multiple attempts of actuating the podh1 when the pull wire has already been retracted by a previous actuation may cause the proximal end of the pusher assembly to be retracted further into the handle and become stuck.Further evaluation revealed that the ruby coil¿s pusher assembly was fractured and kinked in multiple locations along the hypo-tube.This damage was likely incidental and may have occurred during packaging the device for return.Podh1s are 100% functionally tested during incoming inspection.Ruby coils are 100% functionally tested during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: POD DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5625749
• Report Number: 3005168196-2016-00593
• Device Sequence Number: 554759
• Product Code: HCG
• UDI-Device Identifier: 00814548013954
• UDI-Public: 00814548013954
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/04/2016

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: 04/30/2018
• Device Catalogue Number: PODH1
• Device Lot Number: F63545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2016
• Supplement Report FDA Received Date: 06/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1