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

Catalog Number	4004C0406
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Result: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly; the pusher assembly was kinked in multiple locations; the embolization coil¿s stretch resistant wire (sr wire) was fractured and the proximal constraint sphere was inside the pusher assembly distal detachment tip (ddt).The undamaged section of the embolization coil¿s outer diameter (od) was measured and found to be within specification.Conclusion: evaluation of the returned device revealed that the sr wire was fractured.This type of damage likely occurs due to improper handling during use.If the device is forcefully manipulated during retraction, damage such as this may occur.The undamaged section of the embolization coil¿s od was measured and found to be within specification.Further evaluation revealed that the pc400 pusher assembly was kinked in multiple locations.These kinks were likely incidental and may have occurred during packaging the device for return.Pc400s 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coils 400 (pc400).During the procedure, the physician delivered two pc400 coils in the target vessel using a px slim delivery microcatheter (px slim).The physician then advanced a new pc400 through the px slim; however, while attempting to retract the pc400, in order to properly deploy it in the aneurysm, it unintentionally detached within the px slim.The physician did not experience any undue resistance while retracting the pc400 through the px slim.The detached pc400 was removed from the px slim and the procedure was completed using a new pc400 with the same px slim.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5745110
• Report Number: 3005168196-2016-00858
• Device Sequence Number: 16151111
• Product Code: HCG
• UDI-Device Identifier: 00814548011684
• UDI-Public: 00814548011684
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2016

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: 12/31/2019
• Device Catalogue Number: 4004C0406
• Device Lot Number: A61900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2016
• Initial Report FDA Received Date: 06/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1