MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4006C0306
Medical Device Problem Codes	Separation Failure (2547); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2017
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 renal artery using penumbra coils 400 (pc400's).During the procedure, the physician deployed and detached a pod4 and two pc400's in the target vessel using a penumbra coil detachment handle (handle).However, the physician was unable to detach a new pc400 (fourth coil of the procedure) using the same handle despite multiple attempts; therefore, the pc400 was removed.The procedure was completed using the same microcatheter, the same handle, and a new pc400.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 5.0 and 22.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.The pull wire was intact with the distal detachment tip (ddt).The friction lock on the proximal end of the introducer sheath was damaged.Conclusions: evaluation of the returned device revealed that the pet lock was intact on the proximal end of the pusher assembly and the pull wire was inside the ddt.A broken pet lock is an indication that a pull force was applied to the proximal end of the pusher assembly, typically in an attempt was made to detach the coil.If the pusher assembly is not properly seated inside the detachment handle while attempting to detach the coil, it is likely that the pull wire will not retract, the pet lock will not break, and the coil will not detach from its pusher assembly.During the functional analysis a demonstration handle was connected to the proximal end of the pusher assembly and actuated, and the embolization coil detached from its pusher assembly without an issue.The root cause of the reported detachment issue could not be determined.Further evaluation of the returned device revealed that the friction lock on the proximal end of the pusher assembly was damaged.This type of damage likely occurred due to forceful handling during use.Penumbra coils are visually inspected during in-process 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: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6373261
• Report Number: 3005168196-2017-00288
• Device Sequence Number: 769182
• Product Code: HCG
• UDI-Device Identifier: 00814548011837
• UDI-Public: 00814548011837
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2017

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: 11/01/2023
• Device Catalogue Number: 4006C0306
• Device Lot Number: F66288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 04/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1