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

Catalog Number	PODH1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 numbers: 3005168196-2018-00076, 3005168196-2018-00077, 3005168196-2018-00079.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coil detachment handles (ruby handles), a pod detachment handle (pod handle) and ruby coils.During the procedure, the physician successfully deployed and detached multiple ruby coils using a lantern delivery microcatheter (lantern) and a pod handle.The physician then was unable to detach a ruby coil, despite attempting to detach it using the same handle, and two other new handles (f79851, f78388).The ruby coil was eventually able to be detached using a fourth ruby coil handle (f79489).The procedure was then completed using additional ruby coil and the same fourth handle.There was no report of an adverse effect to the patient.

• Brand Name: POD DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7172160
• Report Number: 3005168196-2018-00078
• Device Sequence Number: 13824373
• Product Code: HCG
• UDI-Device Identifier: 00814548013954
• UDI-Public: 00814548013954
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2017

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: 06/19/2020
• Device Catalogue Number: PODH1
• Device Lot Number: F77780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1