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

Catalog Number	4002C1040
Medical Device Problem Codes	Detachment Of Device Component (1104); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra coil 400 (pc400) was detached and intact.The pull wire was protruding distally from the distal detachment tip (ddt).The pusher assembly was kinked approximately 5.0, 68.0, and 141.0 cm from the proximal end.The pull wire, proximal constraint sphere, and ddt were measured and within specification.Conclusions: evaluation of the returned lantern revealed a slight bend on its distal shaft.This damage is likely a result of forceful manipulation while navigating patient anatomy.During functional analysis, a demonstration coil was able to be advanced through the returned device without issue.The slight bend on the returned device may be evidence of a temporary ovalization that could have caused the difficulty advancing the subject coil.Evaluation of the returned pc400 revealed a detached embolization coil, the pet lock was intact, and the pull wire was present inside the ddt.If the embolization coil is retracted against resistance, the pusher assembly may elongate enough so that the pull wire will retract from the ddt effectively detaching the coil.The resistance may have been a result of the coil becoming pinned inside a temporary ovalization of the lantern.No other devices associated with this complaint were returned for evaluation.Penumbra catheters and coils are 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.This report is associated with mfr report numbers: 3005168196-2018-00639, 3005168196-2018-00640.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s) and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully placed two pc400s using the lantern.The physician then felt resistance while advancing another pc400 through the lantern, and therefore attempted to retract the pc400.The pc400 unintentionally detached while being retracted, and the physician therefore removed the lantern with the pc400 inside.The same lantern was then re-advanced, and the physician attempted to place another pc400 through it.The physician again felt resistance advancing, but was able to place and detach the pc400 in the target location.The lantern was then removed, and the procedure was completed using a new microcatheter, ten additional pc400s, and additional coils.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: 7378594
• Report Number: 3005168196-2018-00638
• Device Sequence Number: 1482074
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 00814548010601
• 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
• Report Date (Section B): 02/28/2018

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: 01/22/2025
• Device Catalogue Number: 4002C1040
• Device Lot Number: F73944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1