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

Catalog Number	4002C0830
Medical Device Problem Codes	Peeled/Delaminated (1454); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2016
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coil 400''s (pc400''s).During the procedure, the physician deployed and detached two pc400''s into the target vessel using a px slim delivery microcatheter (px slim).The physician then flushed the px slim and attempted to advance a new pc400 through it.However, the px slim kicked back and the physician lost access to the target vessel.Therefore, the pc400 was retracted.The physician then attempted to resheath the pc400 back into its introducer sheath but encountered resistance was unable to resheath the coil.Upon inspection of the pc400, the physician noticed that the black coating of the alignment zone was peeled off and moved proximal from its appropriate position.Thereafter, the procedure was completed using a new pc400 and the same px slim.It should be noted that the physician used a rotating hemostasis valve (rhv) and flushed the px slim after placing each coil during the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was peeled proximal to its original location on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The embolization coil was intact with its pusher assembly.During functional analysis, the pc400 could not be resheathed due to the peeling of the pet lock.Conclusions: evaluation of the returned device revealed that the pc400 pet lock was peeled proximal of its original location.This type of damage likely occurred due to forceful improper handling during use.If force is applied to the proximal end of the pusher assembly during use, damage such as this may occur.The peeled pet lock likely contributed to the inability to re-sheath the pc400 during the procedure.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: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6296023
• Report Number: 3005168196-2017-00129
• Device Sequence Number: 10996034
• Product Code: HCG
• UDI-Device Identifier: 00814548010564
• UDI-Public: 00814548010564
• 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): 01/04/2017

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: 07/27/2024
• Device Catalogue Number: 4002C0830
• Device Lot Number: F70871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1