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

Catalog Number	4002C2060
Medical Device Problem Codes	Out-Of-Box Failure (2311); Defective Device (2588); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that the following device code also applies to this complaint: (b)(4).This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
During preparation for a coil embolization procedure, the physician noticed that the tip of a penumbra coil 400 (pc400) was already exposed upon removal of the introducer sheath from the dispenser hoop.While the pc400 pusher assembly was being advanced, it was observed that the pc400 was already detached inside its introducer sheath.Therefore, the pc400 was not used for the procedure and did not come into contact with the patient.The procedure was completed using new pc400''s and additional coils.
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 9.5 and 13.5 cm from the proximal end of the pusher assembly.The pull wire was retracted out of the distal detachment tip (ddt) and the embolization coil was detached from its pusher assembly.Conclusions: evaluation of the returned device revealed that the pet lock was broken on the proximal end of the pusher assembly and the embolization coil was detached from its pusher assembly.This type of damage likely occurred due to improper handling during removal from its packaging hoop.If the pet lock is broken and the pull wire is retracted out of its ddt, by design the embolization coil shall detach from the pusher assembly.Since the coil was detached from the pusher assembly, it was able to advance distally out of the introducer sheath, as reported in the initial complaint.The kinks were likely incidental and may have occurred while packaging the device for return.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: 6468224
• Report Number: 3005168196-2017-00545
• Device Sequence Number: 18973425
• Product Code: HCG
• UDI-Device Identifier: 00814548010762
• UDI-Public: 00814548010762
• 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): 03/09/2017

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: 12/29/2023
• Device Catalogue Number: 4002C2060
• Device Lot Number: F67136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1